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 Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects 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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors; Metastatic Solid Tumors
• Intervention / Treatment: Drug: BMS-754807; Drug: Paclitaxel; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Local Institution
    • Parville, Victoria, Australia, 3050
      • Local Institution
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Local Institution
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sequential allocation of patients in two dosing schedules

Drug: BMS-754807; 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; Drug: Paclitaxel; 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; Drug: Carboplatin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3	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 Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamics: Biochemical parameters of drug action in serum	assessed every 6 weeks of the study
Metabolic measures: Effects of the drug on parameters of glucose homeostasis	assessed every 6 weeks of the study
Efficacy Measures: PET scans and tumor assessments by CT/MRI	a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks
Pharmacokinetic Measures: Blood samples will be collected during pre-specified times	Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 18, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): July 13, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Subjects with Advanced or Metastatic Solid Tumors or Neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: CA191-005