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

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221285

Enrollment

Registered

2010-10-26

Start date

2010-10-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : ABT-869 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 2. The subject must have cytologically or histologically confirmed non-squamous NSCLC 3. The subject must have advanced or metastatic (Stage IV [According to AJCC staging manual, 7th edition]) disease that is not amenable to surgical resection or radiation with curative intent. 4. The subject must have not received prior chemotherapy for NSCLC. 18. The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.

Exclusion criteria

Exclusion criteria: 1. The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). 2. The subject has received any anti-cancer therapy for treatment of NSCLC including investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies, hormonal, "targeted" agents, biologic therapy or cytotoxic chemotherapy which includes neo-adjuvant or adjuvant chemotherapy for NSCLC.

Design outcomes

Primary

Measure	Time frame
safety/pharmacokinetics	—

Secondary

Measure	Time frame
efficacy	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026