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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139723
Other study ID # MNT4863g
Secondary ID GO00808
Status Completed
Phase Phase 1
First received June 7, 2010
Last updated November 1, 2016
Start date June 2010
Est. completion date August 2014

Study information

Verified date November 2016
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MINT1526A
Intravenous escalating dose
bevacizumab
Intravenous repeating dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and nature of dose-limiting toxicities (DLTs) Days 1 to 21 of cycle 1 No
Primary 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 No
Secondary Pharmacokinetic parameters of MINT1526A (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state) Following administration of study drug No
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