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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Conditions
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Tumors, Neoplasm Metastasis

Intervention / Treatment
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* Drug: Brivanib
* Drug: Brivanib
* Drug: Brivanib
* Drug: Brivanib
* Drug: Brivanib
* Drug: Brivanab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Brivanib<br>* Tablets, Oral, 180 mg, once daily, until disease progression<br>* Other names: BMS-582664;|
| Experimental: 2<br> | Drug: Brivanib<br>* Tablets, Oral, 320 mg, once daily, until disease progression<br>* Other names: BMS-582664;|
| Experimental: 3<br> | Drug: Brivanib<br>* Tablets, Oral, 600 mg, once daily, until disease progression<br>* Other names: BMS-582664;|
| Experimental: 4<br> | Drug: Brivanib<br>* Tablets, Oral, 800 mg, once daily, until disease progression<br>* Other names: BMS-582664;|
| Experimental: 5<br> | Drug: Brivanib<br>* Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression<br>* Other names: BMS-582664;|
| Experimental: 6<br> | Drug: Brivanab<br>* Tablets, Oral, 1000 mg, once daily, until disease progression<br>* Other names: BMS-582664;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment |  | throughout the study | 
| dose-limiting toxicity (DLT) |  | assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified | 
| determination of maximum tolerated dose (MTD) |  | during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy based on duration of response and time to progression based on assessment |  | measured every 8 weeks throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced metastatic or solid tumors