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

A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420186

Enrollment

Registered

2007-01-09

Start date

2007-10-31

Completion date

2012-02-29

Last updated

2016-09-30

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

Conditions

Cancer (Solid Tumors)

Brief summary

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

Interventions

DRUGBMS-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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®

Design outcomes

Primary

Measure	Time frame
To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation	upon occurrence

Secondary

Measure	Time frame
Describe anti-tumor activity	upon occurence
Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research	upon occurence

Countries

Canada, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026