Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00753480
Other study ID # DMU4506g
Secondary ID
Status Suspended
Phase Phase 1
First received September 12, 2008
Last updated November 6, 2008
Start date September 2008

Study information

Verified date November 2008
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 56
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
D4064A


Locations

Country Name City State
United States Investigational Site Nashville Tennessee
United States Investigational Site New York New York

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and nature of dose-limiting toxicities (DLTs) Length of study
Secondary Incidence, nature, and severity of adverse events Length of study
Secondary Incidence of anti-D4064A antibodies Length of study
Secondary Changes in vital signs and clinical laboratory results Length of study
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2