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
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00793897
First received: November 17, 2008
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Metastatic Solid Tumors |
Drug: BMS-754807 Drug: Paclitaxel Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacodynamics: Biochemical parameters of drug action in serum [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: No ]
- Metabolic measures: Effects of the drug on parameters of glucose homeostasis [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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:
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793897
Locations
| Australia, Victoria | |
| Local Institution | |
| East Melbourne, Victoria, Australia, 3002 | |
| Local Institution | |
| Parville, Victoria, Australia, 3050 | |
| Canada, Alberta | |
| Local Institution | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Local Institution | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Korea, Republic of | |
| Local Institution | |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00793897 History of Changes |
| Other Study ID Numbers: | CA191-005 |
| Study First Received: | November 17, 2008 |
| Last Updated: | July 12, 2012 |
| Health Authority: | Canada: Health Canada Korea: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Bristol-Myers Squibb:
|
Subjects with Advanced or Metastatic Solid Tumors or Neoplasms |
Additional relevant MeSH terms:
|
Neoplasms Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013