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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

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ClinicalTrials.gov Identifier: NCT01139723
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Solid Cancers Drug: MINT1526A Drug: bevacizumab Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: MINT1526A
Intravenous escalating dose
Experimental: B Drug: MINT1526A
Intravenous escalating dose
Drug: bevacizumab
Intravenous repeating dose


Outcome Measures

Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1 to 21 of cycle 1 ]
  2. 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 [ Time Frame: Day 1 to study completion ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters of MINT1526A (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state) [ Time Frame: Following administration of study drug ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139723


Locations
United States, California
Encinitas, California, United States, 92008
Los Angeles, California, United States, 90095
United States, Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Ina Rhee, M.D. Genentech, Inc.
More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01139723     History of Changes
Other Study ID Numbers: MNT4863g
GO00808 ( Other Identifier: Hoffmann-La Roche )
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents