Conditions: Advanced Solid Tumors
Keywords: Treatment Non-Randomized Single Group Assignment Safety Study Neoplasms Carcinoma Cancer Malignancy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 31
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.

Detailed description:
The study was prematurely discontinued on 14 September 2011 due to no significant pharmacological effects (safety/PD/efficacy) through 25 mg/kg cohort, the T1/2 based on VEGF binding was shorter than expected and the current and/or higher doses were not considered feasible for further development. There were no safety concerns associated with the decision to terminate the program/study.

Arms:
arm 1: Weekly infusions of CVX-241 at specified doses

Interventions: intervention 1: CVX-241 intervention 2: CVX-241 intervention 3: CVX-241 intervention 4: CVX-241 intervention 5: CVX-241 intervention 6: CVX-241 intervention 7: CVX-241 intervention 8: CVX-241
Intervention descriptions: intervention 1: 0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops. intervention 2: 1 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops. intervention 3: 3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops. intervention 4: 6 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops. intervention 5: 12 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops. intervention 6: 15 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops. intervention 7: 18 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops. intervention 8: 25 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Protocol document: