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Completed

NCT Number: NCT00479583

Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX

The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Saint-Herblain, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients eligible for FOLFIRI or FOLFOX therapy
  • ECOG performance status score 0-1
  • At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
  • At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
  • No maximum age for Study Arm A (FOLFOX)
  • 18-65 years of age for Study Arm B (FOLFIRI)

Exclusion criteria

  • Treatment with other TKIs within the past 4 weeks
  • Active inflammatory bowel disease
  • Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
  • History of thromboembolism
  • Severe unmanageable diarrhea
  • Uncontrolled or significant cardiovascular disease

Treatment and study plan

BMS-690514 / FOLFIRI

Drug

Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos

BMS-690514 / FOLFOX

Drug

Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos

Primary outcomes

  1. Safety assessment

    Time frame: throughout the study

  2. dose-limiting toxicity (DLT)

    Time frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified

  3. determination of maximum tolerated dose (MTD)

    Time frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified

Secondary outcomes

  1. Describe anti-tumor of combination therapy

    Time frame: Every 8 weeks throughout the study

  2. Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples

    Time frame: throughtout the study

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 FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 28, 2007
Registry last updated
Nov 30, 2011

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.

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