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

NCT00420186 | Completed Phase 1

• 1 other identifier: CA187-004
• Study Type: interventional
• Target: 37
• Locations: 3 countries
• Sites: 4

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

Conditions

Cancer (Solid Tumors)

Outcome Measures

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

  upon occurrence

Secondary Outcomes (2)

• Describe anti-tumor activity

  upon occurence

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

  upon occurence

Study Arms (1)

1

EXPERIMENTAL

Drug: BMS-690514

Interventions

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

Also known as: panHER

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Local Institution

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-690514

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 9, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 30, 2016

Record last verified: 2014-05

Locations

CA (1); US (2); GB (1)