Know Cancer

or
forgot password

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of D4064A Administered Intravenously to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer After a Platinum-Containing Regimen


Phase 1
18 Years
N/A
Not Enrolling
Both
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Thank you

Trial Information

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of D4064A Administered Intravenously to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer After a Platinum-Containing Regimen


Inclusion Criteria:



- ECOG performance status of 0 or 1

- Advanced, histologically documented epithelial ovarian, primary peritoneal, or
fallopian tube cancer that has progressed or relapsed during or within 12 months of
treatment with a platinum-containing chemotherapy regimen, and for which no standard
therapy exists

- History of receiving five or fewer prior chemotherapy-containing regimens for EOC,
PPC, or FTC (including primary therapy)

Exclusion Criteria:

- Prior treatment with chemotherapy or experimental anti-cancer agents within 4 weeks
prior to Day 1

- Prior treatment with oregovomab (OvaRex(R)) or abagovomab

- History or clinical evidence of central nervous system or brain metastases

- Grade ≥ 2 peripheral neuropathy

- History of severe allergic or anaphylactic reactions to human, humanized, chimeric,
or murine monoclonal antibodies

- History of clinically symptomatic liver disease, including viral or other hepatitis,
history of or current alcoholism, or cirrhosis

- Untreated or persistent/recurrent malignancy (other than EOC, PPC, or FTC)

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:

Length of study

Principal Investigator

Scott Holden, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

DMU4506g

NCT ID:

NCT00753480

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • EOC
  • PPC
  • FTC
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Investigational Site New York, New York  10032
Investigational Site Nashville, Tennessee  37203