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 study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01139723
First received: June 7, 2010
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Solid Cancers |
Drug: bevacizumab Drug: MINT1526A |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1 to 21 of cycle 1 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: MINT1526A
Intravenous escalating dose
|
| Experimental: B |
Drug: bevacizumab
Intravenous repeating dose
Drug: MINT1526A
Intravenous escalating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139723
Locations
| United States, California | |
| Encinitas, California, United States, 92008 | |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Ina Rhee, M.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01139723 History of Changes |
| Other Study ID Numbers: | MNT4863g, GO00808 |
| Study First Received: | June 7, 2010 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013