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Trial record 100 of 175 for:    pertuzumab

A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

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.
 
ClinicalTrials.gov Identifier: NCT02004093
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 6, 2013
Results First Submitted Date  ICMJE July 31, 2014
Results First Posted Date  ICMJE December 4, 2014
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE December 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
  • Percentage of Participants With Disease Progression or Death [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks ]
    Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
  • Progression-Free Survival [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks ]
    Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
  • Kaplan-Meier Probability of No Disease or Progression at 1 Year [ Time Frame: 1 year ]
    The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
Progression-free survival \n [ Time Frame: approximately 3 years ]
Change History Complete list of historical versions of study NCT02004093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
  • Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks ]
    Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were "response", "stable disease" and "progressive disease". Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".
  • Duration of Response [ Time Frame: Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks ]
    For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.
  • Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year [ Time Frame: 1 year ]
  • Percentage of Participants With Disease Progression [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression ]
    Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
  • Time to Progressive Disease [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression ]
    The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.
  • Kaplan-Meier Probability of Being Progression Free at 1 Year [ Time Frame: 1 year ]
  • Time To Response [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment ]
    Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.
  • Percentage of Participants Who Died [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment ]
  • Overall Survival [ Time Frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment ]
    Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.
  • Kaplan-Meier Probability of Being Alive at 1 Year [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Overall response rate [ Time Frame: approximately 1 year ]
  • Duration of response [ Time Frame: approximately 3 years ]
  • Time to progression [ Time Frame: approximately 3 years ]
  • Overall survival [ Time Frame: approximately 3 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
Official Title  ICMJE A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Brief Summary This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: pertuzumab
    Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
  • Drug: paclitaxel
    175 mg/m2 IV every 3 weeks for 6 cycles
  • Drug: gemcitabine
    1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
  • Drug: carboplatin
    Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
Study Arms  ICMJE
  • Experimental: Chemotherapy + Pertuzumab
    Interventions:
    • Drug: pertuzumab
    • Drug: paclitaxel
    • Drug: gemcitabine
    • Drug: carboplatin
  • Active Comparator: Chemotherapy
    Interventions:
    • Drug: paclitaxel
    • Drug: gemcitabine
    • Drug: carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
149
Original Actual Enrollment  ICMJE
 (submitted: December 3, 2013)
152
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
  • only 1 previous regimen, which must be platinum-based;
  • platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.

Exclusion Criteria:

  • previous radiotherapy;
  • previous treatment with an anti-cancer vaccine or any targeted therapy;
  • major surgery or traumatic injury within 4 weeks of study;
  • history or evidence of central nervous system metastases.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Hungary,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004093
Other Study ID Numbers  ICMJE BO17931
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP