NCT01952249

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

SIERRA: A Phase 1b/2 Study of Demcizumab Plus Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Phase 1b portion was completed; Phase 2 portion was not initiated. Subjects must not have received prior weekly paclitaxel or more than 3 prior chemotherapy regimens in the Phase 1b portion of the study and more than 2 prior chemotherapy regimens in the Phase 2 portion of the study. Prior to enrollment, subjects will undergo screening to determine study eligibility. In the Phase 1b portion of study, 3 subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from Days 0-28. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. After the final patient in the Phase 1b portion of the trial has completed their Day 28 DLT assessment, 50 subjects will be enrolled in the Phase 2 portion of the study and treated with demcizumab at the highest dose level that had \< 2 DLTs in the 6 subjects.

Conditions

• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Demcizumab	administered intravenously
DRUG	Taxol	administered intravenously

Timeline

• Start date: 2013-08-05
• Primary completion: 2016-05-10
• Completion: 2016-07-12
• First posted: 2013-09-27
• Last updated: 2020-09-09

Locations

3 sites across 1 country: United States