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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01952249
First Posted: September 27, 2013
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
  Purpose
This is a Phase 1b/2 study of paclitaxel plus demcizumab in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer.

Condition Intervention Phase
Primary Peritoneal Carcinoma Drug: Demcizumab Drug: Taxol Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SIERRA: A PhaSe 1b/2 Study of DemcIzumab Plus PaclitaxEl in Subjects With Platinum Resistant OvaRian, PrimAry Peritoneal or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: August 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Demcizumab
Demcizumab will be administered prior to paclitaxel by intravenous (IV) infusion.
Drug: Demcizumab
administered intravenously
Other Name: OMP-21M18
Drug: Taxol
administered intravenously
Experimental: Taxol
demcizumab combined with weekly paclitaxel
Drug: Demcizumab
administered intravenously
Other Name: OMP-21M18
Drug: Taxol
administered intravenously

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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).
  3. 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.
  4. Age >21 years
  5. ECOG performance status <3

Exclusion Criteria:

  1. Subjects receiving any other investigational medicinal product or anti-cancer therapy.
  2. 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)
  3. Non-epithelial ovarian carcinoma, including malignant mixed Mullerian tumors.
  4. 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.
  5. Prior radiotherapy to the pelvis or abdomen
  6. Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving lowdose aspirin and/or non-steroidal anti-inflammatory agents.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
  More Information

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01952249     History of Changes
Other Study ID Numbers: M18-005
First Submitted: September 18, 2013
First Posted: September 27, 2013
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by OncoMed Pharmaceuticals, Inc.:
Ovarian
Primary Peritoneal
Fallopian Tube Cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action