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A Study of the Safety and Pharmacokinetics of MEGF0444A Administered to Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00909740
First received: May 20, 2009
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion 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: MEGF0444A
 Phase 1

Study Type: Interventional
Study Design: 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 MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-21 of cycle 1 ] [ Designated as safety issue: No ]
  • Incidence, nature, relatedness, and severity of adverse events [ Time Frame: Day 1 to study completion ] [ 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: 30
Study Start Date: May 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MEGF0444A
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

Exclusion Criteria:

  • Inadequate hematologic and organ function
  • Anti-cancer therapy within 4 weeks prior to initiation of study treatment
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
  • Active infection or autoimmune disease
  • Pregnancy (positive pregnancy test) or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909740

Sponsors and Collaborators
Genentech
Investigators
Study Director: Louie Naumovski, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00909740     History of Changes
Other Study ID Numbers: MEF4693g
Study First Received: May 20, 2009
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Solid Tumor
Cancer

ClinicalTrials.gov processed this record on May 19, 2013