Status:
COMPLETED
A Study of the Safety and Pharmacokinetics of MINT1526A, Administered Intravenously As a Single Agent and in Combination With Bevacizumab to Patients With Advanced Solid Tumors
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A administered alone and in combination with bevacizumab by IV infusion every 3 weeks to patients with advanced solid tu...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit
- Adequate hematologic and end organ function
- Evaluable disease or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0; prostate cancer patients with nonevaluable or nonmeasurable disease if they have an increase in prostate-specific antigen (PSA); ovarian cancer patients with nonevaluable or nonmeasurable disease if they have an increase in cancer antigen 125 (CA-125)
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for 6 months after discontinuation from the study
Exclusion
- Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy within a specified timeframe prior to initiation of study treatment.
- Leptomeningeal disease
- Active infection requiring intravenous antibiotics
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or prednisone
- Bisphosphonate therapy for symptomatic hypercalcemia
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
- Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
- Pregnancy, lactation, or breastfeeding
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01139723
Start Date
June 1 2010
End Date
August 1 2014
Last Update
November 2 2016
Active Locations (3)
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1
Encinitas, California, United States, 92008
2
Los Angeles, California, United States, 90095
3
Aurora, Colorado, United States, 80045