Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors

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

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-12-31

Brief Summary

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

The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies

NCT00207051

Colorectal Cancer

COMPLETED PHASE1

PhII ICb With/Without Erbitux in MBC Pts

NCT00248287

Metastatic Breast Cancer

ACTIVE_NOT_RECRUITING PHASE2

Safety Study Of Cetuximab Plus Dasatinib (BMS-354825) in Treating Advanced Solid Malignancies

NCT00388427

Malignant Solid Tumour

COMPLETED PHASE1

Study of Cetuximab in Combination With Tarceva in Patients With Solid Tumors

NCT00207077

Neoplasms

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

NCT07223047

Advanced Solid Malignancies Non-small Cell Lung Cancer (NSCLC) Colorectal Cancer (CRC) +1 more

RECRUITING PHASE1/PHASE2

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.

Colorectal Cancer Head and Neck Cancer Neoplasm Metastasis

Study Design

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

Allocation Method

NA

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.

BMS-754807 + cetuximab

Combination

Group Type EXPERIMENTAL

BMS-754807

Intervention Type DRUG

Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision

cetuximab (Erbitux®)

Intervention Type DRUG

IV infusion, IV, 400 mg/m² loading dose, then 250 mg/m², weekly, varies - treatment is continued to disease progression or MD/subject/sponsor decision

Interventions

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

BMS-754807

Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision

Intervention Type DRUG

cetuximab (Erbitux®)

IV infusion, IV, 400 mg/m² loading dose, then 250 mg/m², weekly, varies - treatment is continued to disease progression or MD/subject/sponsor decision

Intervention Type DRUG

Other Intervention Names

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

Eributux®

Eligibility Criteria

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

Inclusion Criteria

* ECOG status 0 - 1
* Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
* Dose expansion: CRC (KRAS-WT) and head \& neck cancer subjects only

1. must be able to provide 2 fresh tumor biopsy samples
2. must have failed one prior cetuximab-containing treatment

Exclusion Criteria

* Symptomatic brain metastasis
* Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
* Any condition requiring chronic use of steroids
* Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
* History of glucose intolerance
* History of cetuximab infusion reactions
* Women of child-bearing potential unwilling or unable to use acceptable contraception methods

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No