MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Tumors; Neoplasm Metastasis

Treatments: Drug: Brivanib; Drug: Brivanab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207103

CA182-002

Details and patient eligibility

About

This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
• No tumor spread to the brain
• Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
• Available tumor tissue sample from prior surgery
• 4-6 weeks since prior therapy and recovered from prior therapy
• Men and women, ages 18 and above
• Women must not be pregnant or breastfeeding
• Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
• Measurable disease on scans (at least one)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 6 patient groups

1

Experimental group

Treatment:

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

2

Experimental group

Treatment:

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

3

Experimental group

Treatment:

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

4

Experimental group

Treatment:

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

5

Experimental group

Treatment:

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

Drug: Brivanib

6

Experimental group

Treatment:

Drug: Brivanab