Clinical trial · Interventional
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
NCT01225302CI-TRIAL-00030461completedPhase 1ClinicalTrials.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 primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Linifanib | Drug | Linifanib | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Drug: Linifanib
- Drug: Carboplatin
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Arm B
- interventionNames
- Drug: Linifanib
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Safety (Number of patients with adverse events and/or dose-limiting toxicities)
- timeFrame
- At each treatment visit (weekly for 6 weeks, then every 3 weeks)
- description
- Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria * The subject must be 20 and older years of age. * The subject must have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non-squamous to be eligible. * The subject must have advanced or metastatic (Stage IV \[According to American Joint Committee on Cancer (AJCC) staging manual, 7th edition\]) disease that is not amenable to surgical resection or radiation with curative intent. * The subject must have not received prior chemotherapy for NSCLC. * The subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. * The subject has an Easter Cooperative Oncology Group (ECOG) Performance Score of 0-1. * The subject must have adequate bone marrow, renal and hepatic function. Exclusion Criteria * The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). * The subject has received any anti-cancer therapy for treatment of NSCLC including investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies, hormonal, "targeted" agents (i.e., erlotinib, imatinib), biologic therapy or cytotoxic chemotherapy (i.e., alkylating agents, microtubule inhibitors, antimetabolites). * The subject has a history of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin. * The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption. * The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities. * The subject is pregnant or breast feeding. * The subject has NSCLC with a predominant squamous cell histology.
References
Publications (1)
- RESULTHorinouchi H, Yamamoto N, Nokihara H, Horai T, Nishio M, Ohyanagi F, Horiike A, Nakagawa K, Terashima M, Okabe T, Kaneda H, McKee MD, Carlson DM, Xiong H, Tamura T. A phase 1 study of linifanib in combination with carboplatin/paclitaxel as first-line treatment of Japanese patients with advanced or metastatic non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2014 Jul;74(1):37-43. doi: 10.1007/s00280-014-2478-9. Epub 2014 May 8. PMID 24807459