Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00050960
• Date of registration: 31/12/2002
• Prospective Registration: No
• Primary sponsor: Eisai Inc.
• Public title: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
• Scientific title: Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
• Date of first enrolment: May 2002
• Target sample size: 612
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00050960
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, Canada, France, Germany, Spain, United States

Contacts

• Name: Mack Mabry, M.D.
• Affiliation: Ligand Pharmaceuticals

Key inclusion & exclusion criteria

Patients must have:

- Pathologic (histologic or cytologic) confirmation of NSCLC

- Stage IIIB with malignant pleural effusion or Stage IV disease

- At least one measurable or evaluable NSCLC lesion that has not been previously
irradiated unless radiation therapy was more than three weeks prior to entry in the
study and the lesion has been shown to have progressed subsequent to the radiation
therapy

- ECOG performance status 0 or 1

- Adequate organ system function

- Fasting serum triglycerides that are within the age-adjusted normal range (or
normalized with appropriate intervention such as antilipid therapy prior to the
initiation of Targretin capsule therapy).

Patients must be able to complete at least four cycles of combination chemotherapy (i.e.,
approximately four months)

Patients must not have had:

- Brain metastasis

- Prior chemotherapy for NSCLC

- Prior platinum-based chemotherapy for any indication



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-small Cell Lung Cancer

Intervention(s)

Drug: bexarotene with carboplatin and paclitaxel

Drug: carboplatin and paclitaxel

Primary Outcome(s)

Overall Survival [Time Frame: From date of randomization to date of death]

Secondary ID(s)

L1069-48

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/08/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00050960