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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by OncoMed Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01952249
First received: September 18, 2013
Last updated: September 24, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Apparent half life, AUC, clearance, volume of distribution


Estimated Enrollment: 62
Study Start Date: August 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   21 Years to 90 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952249

Contacts
Contact: Robert Stagg, PharmD 650-995-8289 robert.stagg@oncomed.com

Locations
United States, Texas
UTMD Anderson Cancer Clinical Lab Recruiting
Houston, Texas, United States, 77030
Contact: Robert Louis Coleman, MD, FACOG, FACS    (713) 745-3357      
Principal Investigator: Robert Louis Coleman, MD, FACOG, FACS         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01952249     History of Changes
Other Study ID Numbers: M18-005
Study First Received: September 18, 2013
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014