NCT01075464

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

February 24, 2010

Last Update Submit

November 1, 2016

Conditions

Solid Cancers

Keywords

Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • Incidence and nature of dose-limiting toxicities (DLTs)

    Days 1 to 28 of Cycle 1

  • Incidence, nature, and severity of adverse events

    Until 90 days after last dose of study treatment

Secondary Outcomes (1)

  • Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution

    Following administration of study drug

Study Arms (2)

A

EXPERIMENTAL
Drug: MEGF0444ADrug: bevacizumab

B

EXPERIMENTAL
Drug: MEGF0444ADrug: bevacizumabDrug: paclitaxel

Interventions

MEGF0444ADRUG

Intravenous escalating dose

AB
bevacizumabDRUG

Intravenous repeating dose

AB
paclitaxelDRUG

Intravenous repeating dose

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Tampa, Florida, 33612, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

parsatuzumabBevacizumabPaclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(5)