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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01075464
First received: February 24, 2010
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combinatio n with bevacizumab, and in combination with bevacizumab and paclitaxel as therap y for locally advanced or metastatic solid tumors.


Condition Intervention Phase
Solid Cancers
Drug: MEGF0444A
Drug: bevacizumab
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 Human IgG1 Antibody, in Combination With Bevacizumab and 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: 64
Study Start Date: February 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MEGF0444A
Intravenous escalating dose
Drug: bevacizumab
Intravenous repeating dose
Experimental: B Drug: MEGF0444A
Intravenous escalating dose
Drug: bevacizumab
Intravenous repeating 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Solid Tumor

Additional relevant MeSH terms:
Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014