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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


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

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: 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 28 of Cycle 1

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MEF4797g

NCT ID:

NCT01075464

Start Date:

February 2010

Completion Date:

June 2013

Related Keywords:

  • Solid Cancers
  • Solid Tumor

Name

Location

Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Nashville, Tennessee  37203-1632