Clinical trial · Interventional
Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)
An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT00517790CI-TRIAL-00009929completedPhase 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)
The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-869 0.10 mg/kg | Drug | — | UNRESOLVED |
| ABT-869 .25 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABT-869 0.25 mg/kg
- description
- Approximately half of the subjects were randomized to receive the high dose
- interventionNames
- Drug: ABT-869 .25 mg/kg
- type
- EXPERIMENTAL
- label
- ABT-869 0.10 mg/kg
- description
- Approximately half of the subjects were randomized to receive the Low Dose
- interventionNames
- Drug: ABT-869 0.10 mg/kg
Primary outcomes (1)
- measure
- Progression Free Rate (PFR)
- timeFrame
- Week 16
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC * Subjects must have at least one lesion measurable by CT scan as defined by RECIST * The measurable lesion may have not received radiation therapy * Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 * Subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic NSCLC. In addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC * Adequate organ function Exclusion Criteria: * Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy. Prior Avastin is allowed. * Subject has untreated brain or meningeal metastases. * History of greater than 10% weight loss * Subject has clinically relevant hemoptysis * The subject has proteinuria CTC Grade \> 1 * The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention. * The subject has a documented left ventricular ejection fraction \< 50%
References
Publications (1)
- DERIVEDTan EH, Goss GD, Salgia R, Besse B, Gandara DR, Hanna NH, Yang JC, Thertulien R, Wertheim M, Mazieres J, Hensing T, Lee C, Gupta N, Pradhan R, Qian J, Qin Q, Scappaticci FA, Ricker JL, Carlson DM, Soo RA. Phase 2 trial of Linifanib (ABT-869) in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2011 Aug;6(8):1418-25. doi: 10.1097/JTO.0b013e318220c93e. PMID 21597387