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NCT Number: NCT01139723

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

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.

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Key information

Conditions

Solid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Encinitas, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MINT1526A

Drug

Intravenous escalating dose

Bevacizumab

Drug

Intravenous repeating dose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 8, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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