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
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2016 |
Start Date: | June 2010 |
End Date: | August 2014 |
A Phase I, Open Label, Dose Escalation 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
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 tumors for whom standard therapy either does not exist or has
proven to be ineffective or intolerable.
administered alone and in combination with bevacizumab by IV infusion every 3 weeks to
patients with advanced solid tumors for whom standard therapy either does not exist or has
proven to be ineffective or intolerable.
Inclusion Criteria:
- 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 Criteria:
- 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
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