Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED) (PROCEED)
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ClinicalTrials.gov Identifier: NCT01170650 |
Recruitment Status
:
Suspended
(DSMB decision)
First Posted
: July 27, 2010
Last Update Posted
: August 4, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | July 7, 2010 | |||
First Posted Date ICMJE | July 27, 2010 | |||
Last Update Posted Date | August 4, 2015 | |||
Study Start Date ICMJE | April 2011 | |||
Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-free survival based on investigator assessment using RECIST v1.1. [ Time Frame: up to 26 months ] Progression is assessed at 6 week intervals through Week 24 and at 8 week intervals thereafter.
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Original Primary Outcome Measures ICMJE |
Progression-free survival based on investigator assessment using RECIST v1.1. [ Time Frame: Approximately 24 months ] Progression is assessed at 6 week intervals through Week 24 and at 8 week intervals thereafter.
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Change History | Complete list of historical versions of study NCT01170650 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED) | |||
Official Title ICMJE | A Randomized Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) in Combination Versus PLD in Participants With Platinum-Resistant Ovarian Cancer | |||
Brief Summary | The purpose of this study is to compare progression-free survival (PFS) (based upon investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with that in participants who receive PLD and placebo. | |||
Detailed Description | This is a Phase 3 clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD and placebo. Enrollment of 640 patients including approximately 500 that are folate receptor positive is planned. EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR) that is not generally found on normal cells. Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence in a small number of Phase I participants, in a subset of participants in a completed single-arm Phase II study, and interim data from an ongoing randomized Phase 2 study (PRECEDENT) suggests that EC145 may have antitumor effect in women with platinum-resistant ovarian cancer and that EC145 alone and in combination with PLD is generally well-tolerated. This evidence suggests that EC145 may be useful as chemotherapy against platinum-resistant ovarian cancer. All participants will undergo imaging with the FR-targeting investigational diagnostic agent EC20 during the screening period to assess binding of the imaging agent EC20 to tumors. This non-invasive procedure will provide additional information on the utility of using EC20 imaging to identify subjects with the FR molecular "target" prior to treatment with EC145 therapy. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
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 Cancer | |||
Intervention ICMJE |
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Study Arms |
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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 | Suspended | |||
Estimated Enrollment ICMJE |
640 | |||
Original Estimated Enrollment ICMJE |
500 | |||
Estimated Study Completion Date | October 2016 | |||
Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01170650 | |||
Other Study ID Numbers ICMJE | 8109-002 EC-FV-06 ( Other Identifier: Endocyte ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Endocyte | |||
Study Sponsor ICMJE | Endocyte | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Endocyte | |||
Verification Date | August 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |