MedDataX Logo

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

NCT ID: NCT00793897

Last Updated: 2012-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors Metastatic Solid Tumors

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Subjects with Advanced or Metastatic Solid Tumors or Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequential allocation of patients in two dosing schedules

Group Type EXPERIMENTAL

BMS-754807

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

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

Carboplatin

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-754807

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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IGF-IR Taxol BMS-181339 Paraplatin BMY-26575

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

East Melbourne, Victoria, Australia

Site Status

Local Institution

Parville, Victoria, Australia

Site Status

Local Institution

Edmonton, Alberta, Canada

Site Status

Local Institution

Hamilton, Ontario, Canada

Site Status

Local Institution

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia Canada South Korea

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA191-005

Identifier Type: -

Identifier Source: org_study_id