A Study of the Safety and Pharmacology of MEGF0444A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01075464
First received: February 24, 2010
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Cancers |
Drug: bevacizumab Drug: MEGF0444A Drug: paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MEGF0444A, a Humanized IgG1 Antibody, in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic 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 28 of Cycle 1 ] [ Designated as safety issue: No ]
- Incidence, nature, and severity of adverse events [ Time Frame: Until 90 days after last dose of study treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution [ Time Frame: Following administration of study drug ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: bevacizumab
Intravenous repeating dose
Drug: MEGF0444A
Intravenous escalating dose
|
| Experimental: B |
Drug: bevacizumab
Intravenous repeating dose
Drug: MEGF0444A
Intravenous escalating dose
Drug: paclitaxel
Intravenous repeating 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
Specific to Arm A:
- For patients undergoing optional or mandatory exploratory MRI, at least one tumor lesion that represents a liver, fixed peritoneal, neck, extremity, or pelvic lesion measuring >/= 3 to 10 cm (for liver lesions) or >= 2 to 10 cm (for all other lesion locations) to be used for MRI
Specific to Arm B:
- Maximum of two prior chemotherapy regimens for metastatic disease
Exclusion Criteria:
- Anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Patients who had to discontinue prior bevacizumab therapy due to intolerable toxicity
- Leptomeningeal disease
- Active infection or autoimmune disease
- 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
- Inadequately controlled hypertension; history of hypertensive crisis or encephalopathy; congestive heart failure (New York Heart Association Class II or greater); history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
- History of hemoptysis; evidence of bleeding diathesis or significant coagulopathy
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment
- Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture
Specific to Arm B:
- Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
- Previous intolerance to paclitaxel
- Grade >= 2 sensory neuropathy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075464
Locations
| United States, Arizona | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| San Francisco, California, United States, 94115 | |
| Santa Monica, California, United States, 90404 | |
| United States, Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01075464 History of Changes |
| Other Study ID Numbers: | MEF4797g, GO01328 |
| Study First Received: | February 24, 2010 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
Solid Tumor |
Additional relevant MeSH terms:
|
Paclitaxel Bevacizumab Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013