A Study of Demcizumab Plus Paclitaxel in Subjects With Platinum Resistant Ovarian (SIERRA)
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|ClinicalTrials.gov Identifier: NCT01952249|
Recruitment Status : Terminated (Phase 2 portion not initiated, no longer pursuing ovarian cancer indication)
First Posted : September 27, 2013
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Peritoneal Carcinoma||Drug: Demcizumab Drug: Taxol||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SIERRA: A Phase 1b/2 Study of Demcizumab Plus Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer|
|Actual Study Start Date :||August 5, 2013|
|Actual Primary Completion Date :||May 10, 2016|
|Actual Study Completion Date :||July 12, 2016|
Demcizumab will be administered prior to paclitaxel by intravenous (IV) infusion.
Other Name: OMP-21M18
demcizumab combined with weekly paclitaxel
Other Name: OMP-21M18
- 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 [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28) ]The maximum tolerated dose (MTD) will be determined in patients treated with demcizumab in combination with weekly paclitaxel
- Pharmacokinetics (PK) of demcizumab when given in combination with weekly paclitaxel [ Time Frame: 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. ]Apparent half life, AUC, clearance, volume of distribution
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952249
|United States, Oklahoma|
|University of Oklahoma Stephenson Cancer Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center Department of Gynecologic Oncology|
|Houston, Texas, United States, 77030|