A Study of Demcizumab Plus Paclitaxel in Subjects With Platinum Resistant Ovarian

NCT01952249 | Terminated Phase 1

• 1 other identifier: M18-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 1b/2 study of paclitaxel plus demcizumab in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer.

Conditions

Primary Peritoneal Carcinoma

Keywords

Ovarian; Primary Peritoneal; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (1)

• Phase 1b: Dose limiting toxicities (DLT) of demcizumab when combined with weekly paclitaxel in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer

  The maximum tolerated dose (MTD) will be determined in patients treated with demcizumab in combination with weekly paclitaxel

  Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)

Secondary Outcomes (1)

• Pharmacokinetics (PK) of demcizumab when given in combination with weekly paclitaxel

  Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the demcizumab infusion on Days 0, 14, 56 and 70 and at the end of the demcizumab infusion (prior to paclitaxel infusion) on Days 0 and 56.

Study Arms (2)

Demcizumab

EXPERIMENTAL

Demcizumab will be administered prior to paclitaxel by intravenous (IV) infusion.

Drug: Demcizumab; Drug: Taxol

Taxol

EXPERIMENTAL

demcizumab combined with weekly paclitaxel

Drug: Demcizumab; Drug: Taxol

Interventions

Demcizumab DRUG

administered intravenously

Also known as: OMP-21M18

Demcizumab; Taxol

Taxol DRUG

administered intravenously

Demcizumab; Taxol

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have cytologically or histologically confirmed ovarian, primary peritoneal or fallopian tube cancer.. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT, PET-CT or MRI (i.e., RECIST version 1.1 measurable disease).
• Subjects must have platinum resistant disease (i.e., which is defined as disease progression in less than 6 months after receiving a minimum of 4 cycles of a platinum containing regimen).
• Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
• Age \>21 years
• ECOG performance status \<3

You may not qualify if:

• Subjects receiving any other investigational medicinal product or anti-cancer therapy.
• Prior therapy with weekly paclitaxel for recurrent disease (administration of weekly paclitaxel as part of an upfront treatment strategy is acceptable as long as the patient had not progressed while receiving weekly paclitaxel or recurred within 4 months of receiving weekly paclitaxel)
• Non-epithelial ovarian carcinoma, including malignant mixed Mullerian tumors.
• For the Phase 1b portion of the study, more than 3 prior chemotherapy regimens and for the Phase 2 portion of the study more than 2 prior chemotherapy regimens. Maintenance therapy following induction chemotherapy does not count as a separate regimen. In addition, hormonal therapy (e.g., tamoxifen or an aromatase inhibitor) does not count as a separate regimen.
• Prior radiotherapy to the pelvis or abdomen
• Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving lowdose aspirin and/or non-steroidal anti-inflammatory agents.

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (3)

University of Oklahoma Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas MD Anderson Cancer Center Department of Gynecologic Oncology

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

demcizumab; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 27, 2013
• Study Start: August 5, 2013
• Primary Completion: May 10, 2016
• Study Completion: July 12, 2016
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (3)