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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00297089
• Date of registration: 27/02/2006
• Prospective Registration: Yes
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer
• Scientific title: 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
• Date of first enrolment: November 2006
• Target sample size: 165
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00297089
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Czech Republic, Greece, Hungary, Netherlands, Slovakia, United States

Contacts

• Name: Gary Gordon, MD
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

NSCLC

Non-Small-Cell Lung Cancer

Intervention(s)

Drug: pemetrexed

Drug: placebo

Drug: ABT-751

Primary Outcome(s)

Progression-free Survival [Time Frame: Subjects may remain on study until disease progression.]

Secondary Outcome(s)

Overall Survival [Time Frame: Subjects may remain on study until disease progression.]

Response Rate [Time Frame: Subjects may remain on study until disease progression.]

Time-to-Progression (TTP) [Time Frame: Subjects may remain on study until disease progression.]

Secondary ID(s)

2006-002830-38

M05-780

Source(s) of Monetary Support

Please refer to primary and secondary sponsors