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

Primary Peritoneal Carcinoma Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Primary Peritoneal Carcinoma

• NCT number: NCT01952249
• Study type: Interventional
• Source: Mereo BioPharma
• Status: Terminated
• Phase: Phase 1
• Start date: August 5, 2013
• Completion date: July 12, 2016