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E. Santos

Moderator of

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    MS 06 - Regulation of Tobacco Products (ID 24)

    • Event: WCLC 2015
    • Type: Mini Symposium
    • Track: Prevention and Tobacco Control
    • Presentations: 4
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      MS06.01 - Global Effects of Smoking, of Quitting, and of Taxing Tobacco (ID 1868)

      14:15 - 15:45  |  Author(s): L. Joossens

      • Abstract
      • Presentation

      Abstract:
      Evidence from countries of all income levels shows that price increases on cigarettes are highly effective in reducing demand. Higher prices induce cessation and prevent initiation of tobacco use. Article 6 of the WHO Framework Convention on Tobacco Control, "Price and Tax Measures to Reduce the Demand for Tobacco", recognizes the importance of this policy and calls on governments to implement tax and price policies to contribute to their national health objectives. Guidelines on Price and Tax Measures to reduce the demand for Tobacco, adopted by the 180 parties to the FCTC at the Sixth Conference of the Parties in October 2014, stipulate: “Any policy to increase tobacco taxes that effectively increases real prices reduces tobacco use. According to the studies referenced in the WHO technical manual on tobacco tax administration and IARC Handbooks of Cancer Prevention: Tobacco Control. Volume 14, the relationship between real prices and tobacco consumption is generally inelastic, meaning that the decline in consumption is less than proportional to the increase in real price. Most estimates of the price elasticity of demand lie between -0.2 and -0.8. In all settings, studies have shown that the price elasticity of demand is higher (in absolute terms) in the long term, meaning that consumption will fall even more in the long term. People with lower socioeconomic status are more responsive to tax and price changes because such changes have a greater impact on their disposable income. As regards the effect of higher taxes and prices on tobacco use by young people, it is estimated that young people are two to three times more responsive to tax and price changes than older people. Therefore, tobacco tax increases are likely to have a significant effect on reducing tobacco consumption, prevalence and initiation among young people, as well as on reducing the chances of young people moving from experimentation to addiction.”[1] [1] Conference of the Parties to the WHO Framework Convention on Tobacco Control, Sixth session, Guidelines for implementation of Article 6 of the WHO FCTC (Price and tax measures to reduce the demand for tobacco), Moscow, Russian Federation,13–18 October 2014.

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      MS06.02 - The Framework Convention on Tobacco Control (ID 1869)

      14:15 - 15:45  |  Author(s): G. Fong

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MS06.03 - FDA Regulation of Tobacco Products in the US (ID 1870)

      14:15 - 15:45  |  Author(s): M. Zeller

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Learning Objectives: • Describe FDA’s authority under the Family Smoking Prevention and Tobacco Control Act and the steps FDA has taken to regulate tobacco products in the 6 years since enactment of the law. • Understand FDA’s Center for Tobacco Products’ (CTP) strategic priorities and CTP’s vision for the regulation of tobacco products to help reduce the death and disease toll caused by tobacco use. • Describe how the CTP Office of Science supports and evaluates research to ensure that CTP has the science base to make regulatory decisions. • Discuss the ways the public health community can engage with FDA to participate in tobacco product regulation. • Identify opportunities to inform FDA action on tobacco to promote public health. Abstract: The landmark Family Smoking Prevention and Tobacco Control Act (TCA) gave the U.S. Food and Drug Administration (FDA) sweeping new authorities to create a healthier future for America’s families by regulating the manufacture, marketing, and distribution of tobacco products. The law, passed by Congress and signed by the President in 2009, gave FDA the authority to establish the Center for Tobacco Products (CTP), which drives powerful change to protect children and families from the dangers of tobacco products. The TCA takes a comprehensive approach—grounded in rigorous, timely science and the law—to improve public health, especially for the next generation. FDA uses its regulatory authority to take action to protect American families, charting a new course for comprehensive change. These actions include: • Developing science-based regulations to safeguard the nation’s health. • Publishing guidance to help the industry comply with regulations for tobacco products. • Conducting retailer inspections to ensure compliance with laws restricting sales of tobacco products to youth, and issuing warning letters and monetary penalties for violations. • Requiring tobacco manufacturers to report the ingredients in their products so FDA can evaluate the harm caused by the ingredients, take steps to reduce the harm, and educate the public about the toxic substances in tobacco products so public health can be improved. • Reviewing proposed modified risk tobacco products before they can be sold. • Restricting the access and attractiveness of cigarettes and smokeless tobacco to young people. • Enforcing the ban on the manufacture and sale of fruit- or candy-flavored cigarettes. • Prohibiting the use of misleading claims such as “low,” “light,” and “mild” that falsely imply that some tobacco products are safer. • Reviewing new tobacco products to determine whether they can be legally marketed. • Launching public information and education campaigns, particularly targeted to youth, about the dangers of regulated tobacco products. • Partnering with other public health agencies to conduct cutting-edge research on a range of topics such as smoking initiation and nicotine addiction. Currently, FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. FDA has also published a proposed rule to bring other products that meet the definition of tobacco product under FDA’s regulatory authority, such e-cigarettes, waterpipes, some or all cigars, and pipe tobacco. Despite major progress over the past half-century tobacco use kills more than 480,000 Americans each year, making it the leading cause of preventable death and disease in the United States.[1] Every day in the United States, nearly 2,900 youth under the age of 18 smoke their first cigarette, and more than 700 youth under age 18 become daily smokers.[2] Nationwide, 5.5 percent of high school students currently use smokeless tobacco.[3] Nearly 9 out of 10 daily adult smokers used their first cigarette before the age of 18.1 On a global level, tobacco use causes nearly six million deaths a year and at current rates could kill up to one billion people this century.[4] Tobacco use is the most important risk factor for cancer causing around 20% of global cancer deaths and around 70% of global lung cancer deaths.[5] Tobacco regulators around the globe seek to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke. We share common priorities and face common challenges in the fight to improve global public health. It is imperative that all global stakeholders, including the medical and scientific community, learn from one another’s successes and failures. In the United States, FDA's unique position as a regulatory agency allows for a framework of decisionmaking based on – and within the limits of – both the science and the law. CTP uses a comprehensive approach as the best way to end the negative health effects of tobacco use. This includes defining policy, issuing regulations, conducting research, educating Americans on regulated tobacco products, and making decisions on whether new products and claims can be marketed—including reviewing and evaluating applications and claims before the products are allowed on the market. CTP educates the public about the harms of tobacco products, working to reduce their appeal and keep them out of the hands of America’s youth. CTP is committed to protecting and improving public health by focusing on three top priorities: • Reduce initiation rates and prevent youth from starting to use tobacco • Encourage tobacco users to quit • Decrease the harms of tobacco product use This session will help the global medical, research, and public health communities understand the authority granted to the FDA to regulate tobacco and how science is used to make the most effective regulatory decisions. FDA staff will describe actions taken by the FDA in the first six years of regulating tobacco products and preview future regulatory priorities. Attendees will learn about specific ways in which they can collaborate with and inform FDA’s work. At the conclusion of this session, attendees will be able to describe the FDA's role, its activities to date and priorities for the future. References: 1. US Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. 2. Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2012 National Survey on Drug Use and Health, NSDUH: Table 4.10A Past Year Initiation of Substance Use Among Persons Aged 12 or Older Who Initiated Use Prior to the Age of 18, by Gender: Numbers in Thousands, 2012 and 2013. Rockville (MD): US Dept of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, 2014. 3. Centers for Disease Control and Prevention. Tobacco Product Use Among Middle and High School Students - United States, 2011-2014. Morbidity and Mortality Weekly Report 2015; 64: 381-385. 4. http://www.who.int/mediacentre/factsheets/fs339/en/ 5. http://www.who.int/mediacentre/factsheets/fs297/en/ The U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act (TCA). This session will help the medical, research, and public health communities understand the authority granted to FDA to regulate tobacco and how science is used to make the most effective regulatory decisions. Mr. Zeller will describe actions taken by the FDA in the first six years of regulating tobacco products and provide an overview of CTP’s strategic priorities. Attendees will learn about specific ways in which they can collaborate with and inform FDA’s work. At the conclusion of this session, attendees will be able to describe the FDA's role, its activities to date and priorities for the future and understand CTP's strategic priorities and vision for the regulation of tobacco products to help reduce the death and disease toll caused by tobacco use.

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      MS06.04 - The Role of Litigation in Controlling Tobacco Use (ID 1871)

      14:15 - 15:45  |  Author(s): R. Daynard

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Product liability litigation has played a critical, if supporting, role in tobacco control. Most prominently, lawsuits brought by US state attorneys general in the mid-1990s seeking reimbursement for expenses incurred in treating residents for smoking-related diseases forced the industry to begin disgorging incriminating internal documents, with over 14 million now available on the internet, detailing industry misbehavior around the world (http://legacy.library.ucsf.edu). Public exposure of these misdeeds made the tobacco industry politically toxic, easing the way for subsequent regulatory legislation. Under the Master Settlement Agreement resolving these cases, the industry agreed to eliminate various marketing techniques and promotional stratagems and pay the states about $10 billion/year, resulting in dramatic cigarette price increases that greatly reduced teenage smoking. Some of that money went into effective tobacco control programs. Every stage of tobacco litigation (initial filings, motions, hearings, decisions, appeals) provides ‘teachable moments’ for public education about the underlying issues: the health consequences of smoking, addictiveness, and tobacco industry misbehavior. The cases dramatize the impact of smoking on real people, not just statistics. Even the industry's counter-spin, that smokers who contract lung cancer ‘assumed the risk’, implicitly acknowledges the reality of the causal link. Product liability litigation can take many forms. Most legal systems allow individuals, including smokers or their survivors, to seek compensation for their financial and emotional losses from product manufacturers that sell unreasonably dangerous products, fail to warn about the dangers of these products, and/or actually lie about these dangers. In the USA, multimillion-dollar punitive damages, designed to deter others from misbehaving like tobacco companies, are sometimes also available. Similar cases can be brought by victims of secondhand smoke, though establishing causation in cases against tobacco manufacturers has proven extremely difficult; obtaining workers compensation from employers, however, has become fairly routine. Injuries from cigarette-caused fires are compensable, since cigarettes with low ignition propensity can easily be manufactured. Injured smokers and non-smokers are not the only possible plaintiffs: as mentioned, many US states were permitted to sue tobacco companies in the 1990s for medical costs incurred in caring for smokers whose diseases could be attributed to tobacco industry misconduct. Similar cases are pending in Israel, and most Canadian provinces now have legislation facilitating such lawsuits. Finally, legal systems sometimes permit consumers with similar claims to proceed in a single class action, greatly reducing litigation costs. In May 2015 a judge in Quebec, Canada awarded more than US$100,000/smoker to a class of about 100,000 smokers with lung or throat cancer or emphysema, as well as about $100 million to another class of addicted smokers. U.S. courts have allowed class actions to go forward to fund medical monitoring programs for long-term smokers, and to compensate smokers who were fooled into thinking that “light” cigarettes were safer than regular cigarettes. Cases can be brought to stop tobacco industry misconduct brought by parties who were not themselves injured by that behavior. Thus, the US Department of Justice brought a successful case against the major tobacco companies to prevent their continued violations of the Racketeer Influenced and Corrupt Organizations Act. And cases can even be brought in some jurisdictions to force the government to protect the lives and health of their citizens. Thus, the Indian Supreme Court insisted upon legislation to protect nonsmokers from secondhand smoke. The efficacy of product liability litigation depends as much on procedural rules as on substantive legal doctrines (legal ‘rights’). In most countries other than the USA, the absence of contingency fees (where plaintiff's lawyers are compensated with a portion of the plaintiff's judgment or settlement, if any) means the lawyers must either provide their services for free or bill their ill, dying, or bereaved clients on an ongoing basis: hence, few such cases are brought. Worse, many legal systems require plaintiffs who lose their cases to pay the defendant's legal costs, thus putting the plaintiff's remaining assets at risk. These unfortunate procedural rules can, of course, be changed by court rule or statute. Going forward Article 4.5 of the WHO Framework Convention on Tobacco Control (FCTC) recognizes that ‘issues relating to liability… are an important part of comprehensive tobacco control’. Article 19, ‘Liability’, provides that ‘Parties shall consider taking legislative action… to deal with… civil liability, including compensation where appropriate’. Legislation correcting the procedural rules that prohibit contingency fees and shift litigation costs to the losing party, permitting consumer class actions, and facilitating healthcare cost recovery lawsuits, are examples of such highly desirable legislative action. Article 19 also encourages parties to assist each other in carrying out legal proceedings and to share relevant information with each other, and invites the Conference of the Parties (COP) to develop ‘appropriate international approaches to these issues’ as well as to support parties in their activities relating to liability. The COP has currently charged an expert group to design a mechanism for collecting, archiving and sharing litigation documents and for providing advice and assistance—electronically or in person—to attorneys bringing liability cases against the tobacco industry. For at least a decade tobacco company defendants in the US have admitted on their websites and ceased to deny in court that smoking is the major cause of lung cancer and chronic obstructive pulmonary disease (COPD), though they often contest the diagnosis or aetiology in particular cases. By contrast, and despite universal availability of the internet, tobacco defendants in Europe and Asia have been remarkably successful in confusing courts on the epidemiology of smoking and disease. The recent acceleration in the globalization of tobacco control efforts, inspired by the FCTC and supported by the Bloomberg and Gates Foundations, and the commitment of parties under Article 12 of the FCTC to conduct public education on tobacco control issues, can be expected to equalize around the world knowledge of basic tobacco epidemiology. Similarly, the presence of millions of easily accessible internal tobacco industry documents on the internet should simplify the process of establishing the liability of the major transnational tobacco companies and their affiliates.

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Author of

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    MINI 28 - Psychological Impact of Lung Cancer and its Treatment (ID 150)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Palliative and Supportive Care
    • Presentations: 1
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      MINI28.13 - Discussant for MINI28.09, MINI28.10, MINI28.11, MINI28.12 (ID 3384)

      16:45 - 18:15  |  Author(s): E. Santos

      • Abstract
      • Presentation

      Abstract not provided

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    ORAL 33 - ALK (ID 145)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL33.03 - Updated Efficacy/Safety Data From the Phase 2 NP28761 Study of Alectinib in ALK+ NSCLC (ID 1261)

      16:45 - 18:15  |  Author(s): E. Santos

      • Abstract
      • Presentation
      • Slides

      Background:
      ALK gene rearrangements occur in approximately 3–6% of patients with non-small-cell lung cancer (NSCLC). Crizotinib has demonstrated efficacy in ALK+ NSCLC, however many patients experience systemic and/or central nervous system (CNS) disease progression within one year of treatment. Alectinib, a CNS-penetrant and highly selective ALK inhibitor, has shown preclinical activity in the CNS (Ou, et al. JTO 2013) and clinical efficacy in crizotinib-naïve (Ohe, et al. ASCO 2015) and pre-treated (Ou, et al. ASCO 2015; Gandhi, et al. ASCO 2015) ALK+ NSCLC patients. We will present updated efficacy and safety outcomes from the phase II NP28761 study (NCT01871805).

      Methods:
      North American patients ≥18 years of age with ALK+ NSCLC (by FDA-approved FISH test), disease progression following first-line crizotinib, and ECOG PS ≤2 were enrolled. Patients received oral alectinib (600mg) twice daily until progression, death or withdrawal. The primary endpoint was overall response rate (ORR) by independent review committee (IRC) using RECIST v1.1. Secondary endpoints included investigator-assessed ORR; progression-free survival (PFS); quality of life (QoL); CNS response rate; disease control rate (DCR); and safety.

      Results:
      At data cut-off (24 October 2014), 87 patients were enrolled in the intent-to-treat population. Median age was 54 years; 74% had received prior chemotherapy; 60% of patients had baseline CNS metastases, of whom 65% (34/52) had prior brain radiation therapy. Median follow-up was 20.7 weeks. ORR by IRC was 48% (95% CI 36–60); median PFS was 6.3 months (Table 1). In patients with measurable CNS lesions at baseline (n=16), IRC CNS ORR was 69% (95% CI 41–89) and CNS DCR was 100% (complete response, 13%; partial response, 56%; stable disease, 31%). In patients with measurable or non-measurable CNS disease (n=52), IRC CNS ORR was 39% (95% CI 25–53) and 11 patients (21%) had complete CNS responses. The most common grade ≥3 AEs were elevated levels of blood creatine phosphokinase (8%), alanine aminotransferase (6%) and aspartate aminotransferase (5%); no GI toxicities leading to treatment withdrawal were reported. Clinically meaningful improvements were seen in EORTC QLQ-C30 items, including Global Health Status. Figure 1



      Conclusion:
      Alectinib (600mg twice daily) was well tolerated and demonstrated clinical efficacy in patients with ALK+ NSCLC disease who had progressed on prior crizotinib. A clinical benefit with alectinib was also observed in patients with CNS lesions at baseline. These data are preliminary; updated efficacy and safety data from a cut-off date of 27 April 2015 will be presented.

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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-088 - <em>nab</em>-Paclitaxel + Carboplatin for Elderly Patients with Advanced NSCLC (ABOUND.70+) (ID 1084)

      09:30 - 17:00  |  Author(s): E. Santos

      • Abstract
      • Slides

      Background:
      Treatment of elderly patients with non-small cell lung cancer (NSCLC) is challenging due to comorbidities and reduced tolerability; as a result, these patients often receive suboptimal treatment. In addition, 5-year survival rates are lower in elderly than in younger patients with NSCLC. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly increased median overall survival (OS) vs solvent-based paclitaxel plus C in a subset of patients ≥ 70 years of age with advanced NSCLC (19.9 vs 10.4 months; HR 0.583; P = 0.009; Socinski et al. Ann Oncol. 2013;24:314-321). However, 55% of elderly patients treated with nab-P/C required dose reductions and 84% had dose delays, primarily due to adverse events, including myelosuppression. In the open-label, multicenter phase IV ABOUND.70+ trial, the safety and efficacy of 2 different schedules of first-line nab-P/C treatment will be evaluated prospectively in elderly patients with advanced NSCLC.

      Methods:
      Approximately 284 patients with NSCLC ≥ 70 years of age who are not candidates for curative surgery or radiation therapy will be randomized 1:1 to nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1, 8, and 15 plus C AUC 6 on day 1 every 21 days or the same nab-P/C dose every 21 days followed by a 1-week break. Key eligibility criteria include histologically/cytologically confirmed locally advanced or metastatic NSCLC, no prior chemotherapy for metastatic disease, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, and absence of preexisting peripheral neuropathy (PN) grade > 2. Patients will be stratified by ECOG performance status (0 vs 1) and histology (squamous vs nonsquamous). ClinicalTrials.gov identifier NCT02151149.

      Key Endpoints
      Primary Percentage of patients developing either PN grade ≥ 2 or myelosuppression grade ≥ 3
      Secondary Safety Progression-free survival OS Overall response rate
      Exploratory[a] Healthcare resource utilization throughout the study Changes in quality of life
      [a] Additional exploratory endpoints may be defined in the statistical analysis plan if applicable.

      Results:
      TPS Abstract Section NA

      Conclusion:
      TPS Abstract Section NA

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    P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Small Cell Lung Cancer
    • Presentations: 1
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      P2.07-010 - Alisertib (MLN8237)+Paclitaxel versus Placebo+Paclitaxel for Relapsed SCLC (ID 1158)

      09:30 - 17:00  |  Author(s): E. Santos

      • Abstract
      • Slides

      Background:
      Small cell lung cancer (SCLC) is an aggressive malignant disease comprising approximately 14% of all lung cancers, with approximately 31,000 new diagnoses each year in the USA. SCLC has a very poor prognosis, particularly in patients presenting with extensive stage disease. Platinum-based combinations are standard first-line therapy for SCLC; however, relapse is almost universal (≥85%) and patients require further treatment in subsequent lines. Effective new targeted therapies are needed to improve the poor outcomes observed in SCLC. Alisertib is an investigational, orally available, selective inhibitor of Aurora A kinase. Alisertib has shown single-agent antitumor activity in preclinical in vivo models of SCLC and has demonstrated synergism with paclitaxel in this setting. Single-agent alisertib has demonstrated promising efficacy in patients with relapsed/refractory SCLC (Melichar B, et al. Lancet Oncol 2015;16[4]:395–405). Further, phase 1 and 2 evaluation of alisertib+paclitaxel in patients with relapsed ovarian cancer and breast cancer has suggested the antitumor activity of this combination (Falchook G, et al. Int J Gynecol Cancer 2013;23[8] Suppl_1:abstract; Coleman R, et al. Ann Oncol 2014;25[Suppl_4]:abstract 876O). Here we describe the design and objectives of an ongoing phase 2, randomized, double-blind, placebo-controlled study of alisertib+paclitaxel versus placebo+paclitaxel in patients with relapsed SCLC and previously treated with only one line of platinum-based therapy (NCT02038647).

      Methods:
      Approximately 166 adult patients with relapsed SCLC after standard first-line platinum-based therapy, measurable disease by RECIST v1.1, and Eastern Cooperative Oncology Group performance status 0 or 1 will be enrolled at approximately 80 sites in the USA and Europe. Patients will be randomized 1:1 (stratified by type of relapse [sensitive vs resistant/refractory] and presence of brain metastases) to receive 28-day cycles of either alisertib 40 mg or matched placebo PO twice daily on days 1−3, 8−10, and 15−17, plus paclitaxel 60 or 80 mg/m[2 ]IV, respectively, on days 1, 8, and 15, until disease progression or unacceptable toxicity. The primary endpoint of the trial is progression-free survival (PFS). Assuming a hazard ratio of 0.6 for PFS, a total of 138 progression/death events will be required to provide 85% power (two-sided alpha=0.05). Secondary endpoints include: overall and complete response rates; disease control rate; duration of response; overall survival; safety (NCI-CTCAE v4.03); alisertib pharmacokinetics; and symptom-related endpoints (symptom score, time to symptom relief, time to symptom progression). Evaluation of candidate biomarkers in tumor tissue specimens and in circulating tumor cells (CTC)/circulating tumor DNA, change from baseline in CTC numbers, and health-related quality of life (EORTC QLQ-C30/QLQ-LC13 instruments) are exploratory endpoints. As of 10 April 2015, there are 60 sites open in 6 countries with 90 patients randomized. The study continues to enroll patients.

      Results:
      not applicable

      Conclusion:
      not applicable

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