Trial Information
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced 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
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
Type of Study:
Interventional
Study Design:
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 1-21 of cycle 1
Safety Issue:
No
Principal Investigator
Louie Naumovski, M.D., Ph.D.
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
MEF4693g
NCT ID:
NCT00909740
Start Date:
May 2009
Completion Date:
October 2011
Related Keywords:
- Solid Cancers
- Solid Tumor
- Cancer