A Study of Pertuzumab in Combination With Standard Chemotherapy in Women With Recurrent Platinum-Resistant Epithelian Ovarian Cancer and Low HER3 mRNA Expression

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01684878
First received: September 11, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This two-part, multicenter study will evaluate the safety and efficacy of pertuz umab in combination with standard chemotherapy in women with recurrent platinum- resistant epithelian ovarian cancer. In the non-randomized Part 1 safety run-in, patients will receive pertuzumab (840 mg iv loading dose followed by 420 mg eve ry 3 weeks) plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, patients will receive either pertuzumab (840 mg iv loading dose followed by 420 mg every 3 weeks) or placebo in combination with chemother apy (topotecan, paclitaxel, or gemcitabine). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Ovarian Cancer
Drug: pertuzumab
Drug: placebo
Drug: chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A TWO-PART, RANDOMIZED PHASE III, DOUBLE-BLIND, MULTICENTER TRIAL ASSESSING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH STANDARD CHEMOTHERAPY VS. PLACEBO PLUS STANDARD CHEMOTHERAPY IN WOMEN WITH RECURRENT PLATINUM-RESISTANT EPITHELIAL OVARIAN CANCER AND LOW HER3 mRNA EXPRESSION

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Part 1: Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Part 2: Progression-free survival, tumor assessments according to RECIST version 1.1 or Gynecologic Cancer InterGroup (GCIG) criteria [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part 2: Progression-free survival [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Part 1: Progression-free survival [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Part 2: Overall survival [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Part 2: Objective response rate [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Part 2: Biological progression-free interval [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Part 2: Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Part 2: Quality of life: Quality of Life/Functional Assessment Questionnaires [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 184
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab+Chemotherapy Drug: pertuzumab
840 mg intravenous loading dose, followed by 420 mg every 3 weeks
Drug: chemotherapy
Standard chemotherapy (topotecan, paclitaxel, or gemcitabine)
Active Comparator: Placebo+Chemotherapy Drug: placebo
Pertuzumab placebo intravenously every 3 weeks
Drug: chemotherapy
Standard chemotherapy (topotecan, paclitaxel, or gemcitabine)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients, >/= 18 years of age
  • Histologically or cytologically confirmed epithelian ovarian cancer that is platinum-resistant or refractory
  • Low HER3 mRNA expression
  • At least one measurable and/or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (EOCD) performance status 0 to 2
  • Left ventricular ejection fraction (LVEF) greater tha or equal to 50%
  • Negative serum pregnancy test in women of childbearing potential
  • Women of childbearing potential must agree to use effective contraception as defined by protocol during and for at least 6 months post study treatment

Exclusion Criteria:

  • Non-epithelial tumors
  • Ovarian tumors with low malignant potential (i.e. borderline tumors)
  • History of another malignancy within the last 5 years, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  • Previous treatment with more than 2 chemotherapy regimens
  • Any prior radiotherapy to the pelvis or abdomen
  • Pre-existing peripheral neuropathy >/= CTC grade 2
  • Inadequate organ function
  • Uncontrolled hypertension or clinically significant cardiovascular disease
  • Hepatitis B, hepatitis C or HIV infection
  • Current chronic daily treatment with corticosteroids >/= 10 mg per day of methylprednisolone or equivalent, excluding inhaled steroids History of receiving any investigational treatment within 28 days prior to first study drug administration, including prior enrollment into Part 1 of the study
  • Concurrent participation in any clinical trial
  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: NCT01684878

Contacts
Contact: Reference Study ID Number: MO28113 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 68 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01684878     History of Changes
Other Study ID Numbers: MO28113, 2011-005975-17
Study First Received: September 11, 2012
Last Updated: July 21, 2014
Health Authority: Spain: Health Authority Spain

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 24, 2014