A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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

Status

Suspended

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753480

Enrollment

Registered

2008-09-16

Start date

2008-09-30

Completion date

Unknown

Last updated

2008-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Keywords

EOC, PPC, FTC

Brief summary

This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A administered by IV infusion to patients with recurrent or persistent epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have previously received a platinum-containing regimen. The study will enroll up to 56 patients at up to six investigative sites in the United States.

Interventions

DRUGD4064A

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Incidence and nature of dose-limiting toxicities (DLTs)	Length of study

Secondary

Measure	Time frame
Incidence, nature, and severity of adverse events	Length of study
Incidence of anti-D4064A antibodies	Length of study
Changes in vital signs and clinical laboratory results	Length of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026