Clinical trial · Interventional
A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer
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
NCT00297089CI-TRIAL-00009230completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-751 | Drug | — | UNRESOLVED |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Pemetrexed + ABT-751
- interventionNames
- Drug: ABT-751
- Drug: pemetrexed
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Pemetrexed + placebo
- interventionNames
- Drug: pemetrexed
- Drug: placebo
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Subjects may remain on study until disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRudin CM, Mauer A, Smakal M, Juergens R, Spelda S, Wertheim M, Coates A, McKeegan E, Ansell P, Zhou X, Qian J, Pradhan R, Dowell B, Krivoshik A, Gordon G. Phase I/II study of pemetrexed with or without ABT-751 in advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1075-82. doi: 10.1200/JCO.2010.32.5944. Epub 2011 Feb 7. PMID 21300929