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First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer

NCT01337154 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-06-28

No results posted yet for this study

Summary

The goal of this study is to determine the progression-free survival and objective response rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as twice daily orally, or an equal number of matching placebo tablets, starting 1 week before chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Conditions

  • Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion
  • Stage IV Non-small Cell Lung Cancer

Interventions

DRUG

Tamibarotene

Tablet, 6 mg/m2, oral, divided into twice a day dosing.

DRUG

Placebo

Tablets, orally, daily

Sponsors & Collaborators

  • CytRx

    lead INDUSTRY

Principal Investigators

  • Oscar Arrieta, M.D. · Instituto Nacional de Cancerologia, Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Bulgaria
  • India
  • Mexico
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337154 on ClinicalTrials.gov