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Completed

NCT Number: NCT00793897

Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors

A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with paclitaxel and carboplatin for Phase 2 studies

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Key information

Conditions

Advanced Solid Tumors Metastatic Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, East Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy
  • ECOG performance status 0-1
  • At least 4 weeks between surgery or last dose prior anti-cancer therapy

Exclusion criteria

  • Symptomatic brain metastases
  • Any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
  • Uncontrolled or significant cardiovascular disease
  • Inadequate bone marrow, liver or kidney function
  • Evidence of > Grade 1 peripheral neuropathy

Treatment and study plan

BMS-754807

Drug

Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request

Other names: IGF-IR

paclitaxel

Drug

Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Other names: Taxol, BMS-181339

carboplatin

Drug

Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Other names: Paraplatin, BMY-26575

Primary outcomes

  1. Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3

    Time frame: Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose

Secondary outcomes

  1. Pharmacodynamics: Biochemical parameters of drug action in serum

    Time frame: assessed every 6 weeks of the study

  2. Metabolic measures: Effects of the drug on parameters of glucose homeostasis

    Time frame: assessed every 6 weeks of the study

  3. Efficacy Measures: PET scans and tumor assessments by CT/MRI

    Time frame: a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks

  4. Pharmacokinetic Measures: Blood samples will be collected during pre-specified times

    Time frame: Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2008
Registry last updated
Jul 13, 2012

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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