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A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Cancers

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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

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