A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin

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Detailed Description

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Conditions

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Cancer (Solid Tumors)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

BMS-690514

Intervention Type DRUG

Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos

Interventions

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BMS-690514

Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos

Intervention Type DRUG

Other Intervention Names

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panHER

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
* Centrally located squamous cell carcinoma of the lung is permitted
* ECOG performance status of 0-1
* Life expectancy of at least 3 months
* Men and women age 18 and above

Exclusion Criteria

* Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
* Peripheral neuropathy ≥Grade 1 for any reason
* History of thromboembolic disease or bleeding diatheses within the last 6 months
* Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
* Serious, uncontrolled medical disorder or active infection
* Uncontrolled or significant cardiac disease
* Uncontrolled hypertension (150/100)
* Allergy to Cremophor EL®

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No