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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Cancers

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence and nature of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Days 1 to 21 of cycle 1

Safety Issue:

No

Principal Investigator

Ina Rhee, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MNT4863g

NCT ID:

NCT01139723

Start Date:

June 2010

Completion Date:

November 2013

Related Keywords:

  • Solid Cancers

Name

Location

Fountain Valley, California  92708
Denver, Colorado