Protocol CA165020: A Randomized, Two -Cohort Phase II Study of Two Doses of BMS-275183 Given On a Weekly Schedule in Patients with Pre-Treated Non- Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000119-24-ES

Enrollment

180

Registered

2004-10-05

Start date

2004-11-18

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

LUNG CANCER(NSCLC)

Interventions

Product Name: BMS-275183 Product Code: BMS-275183 Pharmaceutical Form: Capsule* CAS Number: 355113-98-3 Current Sponsor code: BMS-275183-01 Concentration unit: mg milligram(s) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subject population will consist of patients with histologically modified or cytologically confirmed NSCLC and uni-or bidimensionally measurable disease by modified WHO criteria. Patients must have progressive disease (PD) during or following therapy with one prior cisplatin or carboplatin based regimen given for Stage III or IV NSCLC or for recurrent metastatic disease (Cohort 1) and patients who are considered to be resistant to treatment with platinum, docetaxel and gefitinib or erlotinib given for Stage III or IV or for recurrent metastatic NSCLC (Cohort 2). Prior treatment with paclitaxel is allowed in both cohorts but no prior treatment with docetaxel is allowed in Cohort 1 only. Patients must demonstrate adequate recovery from recent surgery, chemotherapy and radiation therapy. Patients must have adequate hematologic, hepatic and renal functions. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: More than one prior chemotherapy regimen for recurrent or metastatic NSCLC for patients in Cohort 1 and more than 3 prior chemotherapy regimens for recurrent or metastatic NSCLC for patients in Cohort 2. Recent significant cardiovascular disease. Active brain metastases.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the clinical activity of each of two doses of BMS-275183 given PO as a single dose once a week on a continuous weekly schedule, as measured by the tumor response rate in two seperate cohorts of patients with NSCLC who have failed (i.e. progressed) during or following one prior platinum based chemotherapy regimen given for Stage III or IV NSCLC or for current metastatic disease (Cohort 1) or in patients with NSCLC who are resistant to prior platinum and docetaxel- based chemotherapy, and gefitinib or erlotinib given for Stage III or IV NSCLC or for recurrent metastatic disease (Cohort 2). ;Secondary Objective: To evaluate the safety of each of two doses of BMS-275183 given PO as a single dose once a week on a continuous weekly schedule, to assess the response duration, time to response, progression- free survival (PFS) and overall survival; to evaluate the impact of treatment with BMS-275183 on lung cancer symptoms.;Primary end point(s): The primary efficacy analysis will be tumour response rates (as determined by the Sponsor) in response-evaluable patients.	—

Measure

Time frame

Main Objective: To assess the clinical activity of each of two doses of BMS-275183 given PO as a single dose once a week on a continuous weekly schedule, as measured by the tumor response rate in two seperate cohorts of patients with NSCLC who have failed (i.e. progressed) during or following one prior platinum based chemotherapy regimen given for Stage III or IV NSCLC or for current metastatic disease (Cohort 1) or in patients with NSCLC who are resistant to prior platinum and docetaxel- based chemotherapy, and gefitinib or erlotinib given for Stage III or IV NSCLC or for recurrent metastatic disease (Cohort 2). ;Secondary Objective: To evaluate the safety of each of two doses of BMS-275183 given PO as a single dose once a week on a continuous weekly schedule, to assess the response duration, time to response, progression- free survival (PFS) and overall survival; to evaluate the impact of treatment with BMS-275183 on lung cancer symptoms.;Primary end point(s): The primary efficacy analysis will be tumour response rates (as determined by the Sponsor) in response-evaluable patients.

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Countries

Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026