A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2.

Official Title
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A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT 751 in Combination With Pemetrexed Versus Pemetrexed Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
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Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: ABT-751
* Drug: pemetrexed
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically documented NSCLC Locally advanced (Stage III) or metastatic (Stage IV) NSCLC Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy) Only one prior anti-tumor treatment regimen in the curative setting Progressive disease following the previous anti-tumor treatment regimen Measurable disease by RECIST criteria Brain metastasis must be stable and well-controlled ECOG performance score 0-2 All anti-tumor therapy discontinued at least 3 weeks prior to study entry All adverse events from prior treatment are resolved or stable Adequate hematologic, renal, and hepatic function Females must not be pregnant Willing to take adequate measures to prevent pregnancy Life expectancy of at least 3 months Able to complete the Quality of Life questionnaire Voluntarily signed informed consent Exclusion Criteria: Greater than Grade 1 neurological findings Allergy to sulfa medications Previous treatment with ABT-751 or pemetrexed Receipt of more than one investigational agent for NSCLC Significant weight loss (>10%) within 6 weeks of study entry Glucose-6-phosphate dehydrogenase deficiency or porphyria Significant systemic disease that would adversely affect participation Class 3-4 New York Heart Association classification status Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Pemetrexed + ABT-751 | Drug: ABT-751<br>* 200 mg ABT-751 daily for 14 days every 21 days<br>Drug: pemetrexed<br>* Standard pemetrexed every 21 days<br>* Other names: Alimta;|
| Placebo Comparator: B<br>Pemetrexed + placebo | Drug: pemetrexed<br>* Standard pemetrexed every 21 days<br>* Other names: Alimta;Drug: placebo<br>* Placebo daily for 14 days every 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | Subjects may remain on study until disease progression. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Subjects may remain on study until disease progression. | 
| Response Rate |  | Subjects may remain on study until disease progression. | 
| Time-to-Progression (TTP) |  | Subjects may remain on study until disease progression. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, ABT-751, NSCLC, Alimta, Non-Small-Cell Lung Cancer, pemetrexed