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

Phase 1

Completed

• Conditions: Solid Cancers
• Interventions: Drug: MINT1526A; Drug: bevacizumab

• Registration Number: NCT01139723
• Lead Sponsor: Genentech, Inc.

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 tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	MINT1526A	-
B	MINT1526A	-
B	bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Incidence, nature, and severity of adverse events and serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0	Day 1 to study completion
Incidence and nature of dose-limiting toxicities (DLTs)	Days 1 to 21 of cycle 1

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of MINT1526A (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state)	Following administration of study drug