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

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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.


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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