Skip to main content
OpenTrials
Completed

NCT Number: NCT00420186

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer (Solid Tumors) Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

BMS-690514

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

Other names: panHER

Primary outcomes

  1. To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation

    Time frame: upon occurrence

Secondary outcomes

  1. Describe anti-tumor activity

    Time frame: upon occurence

  2. Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research

    Time frame: upon occurence

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2007
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.