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TERMINATEDPHASE2

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

A Randomized, Placebo-Controlled Phase 2b Study of Tamibarotene Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin as First Line Treatment for Subjects With Advanced Non-Small Cell Lung Cancer

NCT01337154•CytRx

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must be at least 18 years of age
•Subjects must have pathological findings consistent with primary non-small cell lung cancer of any histology.
•Subjects must have either stage IIIB with pleural effusion or IV NSCLC with radiographically measurable disease (RECIST 1.1 criteria). Women non-smokers with stage IV NSCLC should be screened for EGFR mutation and if positive be excluded from the study and placed on an EGFR kinase inhibitor.
•Subjects must have an ECOG Performance Status ≤2.
•If corticosteroids are required for controlling cerebral edema, subjects must be on a stable dose for at least 1 week.
•Subjects must have recovered from any toxicity of prior therapies.
•Subjects must be at least 4 weeks removed from surgery or radiation therapy.
•Subjects must have a life expectancy of at least 12 weeks.
•Subjects must have adequate bone marrow function (defined as an absolute neutrophil count of ≥1500 cells/mm3 and platelet count ≥100,000 cells/mm3), liver function with total bilirubin ≤2.0 mg/dL, and serum creatinine ≤1.5 x institutional ULN.
•Subjects must be able to understand and be willing to sign a written informed consent document.
+9 more criteria

Exclusion Criteria

•Subjects who have received or are currently receiving chemotherapy or antibody therapy, or are enrolled in another treatment clinical trial.
•Subjects with a coagulopathy or bleeding disorder.
•Clinically evident congestive heart failure \>class II of the New York Heart Association (NYHA) guidelines.
•Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
•History or signs of active coronary artery disease with or without angina pectoris (i.e. myocardial infarction with 6 months prior to enrollment, uncontrolled angina, electrocardiographic evidence of acute ischemia).
•Subjects who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol or may not be able to comply with the safety monitoring requirements of the study.
•HIV-positive subjects; however, subjects will not be routinely screened for HIV.
•Subjects who are allergic to any of the intended chemotherapies.
•Female subjects who are pregnant or breast-feeding.
•Active, clinically significant serious infection requiring treatment with antibiotics, antivirals, or antifungals.
+2 more criteria

Locations (26)

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, United States

Kansas City Cancer Center

Kansas City, Kansas, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Department of Medical Oncology, Specialized Hospital for Active Treatment of Oncological Diseases

Sofia, Bulgaria

Medical Oncology Clinic, Multiprofile Hospital for Active Treatment

Varna, Bulgaria

Department of Medical Oncology, Complex Oncology Center

Veliko Tarnovo, Bulgaria

NIZAM's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

M S Patel Cancer Centre, Shree Krishna Hospital

Anand, Gujarat, India

Curie Manavata Cancer Centre

Nashik, Maharashtra, India

Shatabdi Super Speciality Hospital

Nashik, Maharashtra, India

Key Dates

Start Date

April 1, 2011

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

June 28, 2013

Enrollment

140

ACTUAL participants

Conditions

Stage IIIB Non-small Cell Lung Cancer With Pleural EffusionStage IV Non-small Cell Lung Cancer

Interventions

Tamibarotene

DRUG

Placebo

DRUG

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Stage IV Non-small Cell Lung CancerStage IV Malignant Melanoma+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

CISH Inactivated TILs in the Treatment of NSCLC

Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Collection of Blood Samples in Patients With Non-small Cell Lung Cancer