Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00718523 |
Recruitment Status :
Terminated
(The steering committee of the TRIO014 study has taken the decision to stop the TRIO014 trial.)
First Posted : July 18, 2008
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
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Sponsor:
Translational Research in Oncology
Information provided by (Responsible Party):
Translational Research in Oncology
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Tracking Information | ||||
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First Submitted Date ICMJE | July 17, 2008 | |||
First Posted Date ICMJE | July 18, 2008 | |||
Results First Submitted Date ICMJE | October 22, 2015 | |||
Results First Posted Date ICMJE | January 12, 2016 | |||
Last Update Posted Date | January 12, 2016 | |||
Study Start Date ICMJE | January 2009 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death. [ Time Frame: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle ] A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
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Original Primary Outcome Measures ICMJE |
Progression Free Survival (PFS), which is defined as the time from randomization until date of progression or death will be the primary endpoint of this study [ Time Frame: 96 PFS Events - approximately 34 months after the 1st patient is randomized ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Time To Progression (TTP) is defined as the interval from the date of randomization to the date of disease progression [ Time Frame: Once 96 PFS events occured - approximately 34 months after the 1st patient is randomized ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer | |||
Brief Summary | This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
170 | |||
Original Estimated Enrollment ICMJE |
160 | |||
Actual Study Completion Date ICMJE | November 2014 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Canada, France, Germany, Ireland, Israel, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00718523 | |||
Other Study ID Numbers ICMJE | TRIO 014 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Translational Research in Oncology | |||
Original Responsible Party | Mary-Ann LINDSAY, PharmD, CIRG | |||
Current Study Sponsor ICMJE | Translational Research in Oncology | |||
Original Study Sponsor ICMJE | Cancer International Research Group (CIRG) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Translational Research in Oncology | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |