PTX-200 and Carboplatin in Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT01690468 |
Recruitment Status :
Terminated
(Enrollment stopped prior to Phase 1b, change in strategic focus)
First Posted : September 21, 2012
Last Update Posted : September 24, 2020
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Sponsor:
Prescient Therapeutics, Ltd.
Information provided by (Responsible Party):
Prescient Therapeutics, Ltd.
Tracking Information | ||||
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First Submitted Date ICMJE | September 19, 2012 | |||
First Posted Date ICMJE | September 21, 2012 | |||
Last Update Posted Date | September 24, 2020 | |||
Actual Study Start Date ICMJE | September 2014 | |||
Actual Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Maximum Tolerated Dose (MTD) [ Time Frame: 6 months ] To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | PTX-200 and Carboplatin in Ovarian Cancer | |||
Official Title ICMJE | A Phase IA/IB Trial of PTX-200 and Carboplatin in Patients With Platinum-Resistant Recurrent Ovarian Cancer | |||
Brief Summary | The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer. | |||
Detailed Description | The purpose of this study is to investigate the safety and tolerability, and determine the maximum tolerated dose of triciribine when combined with carboplatin in women with platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to evaluate the clinical activity of carboplatin plus triciribine in women with recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate, progression-free survival, and duration of stable disease. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Triciribine & Carboplatin
Phase I/II: 25mg/m^2 Triciribine and Carboplatin AUC 4. Triciribine escalated to 30, 35, 45mg/m^2 if toxicities are not encountered. Phase II: Recommended phase II dose of triciribine and carboplatin. Interventions:
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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 |
15 | |||
Original Estimated Enrollment ICMJE |
45 | |||
Actual Study Completion Date ICMJE | December 2019 | |||
Actual Primary Completion Date | December 2019 (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01690468 | |||
Other Study ID Numbers ICMJE | MCC-18641 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Prescient Therapeutics, Ltd. | |||
Study Sponsor ICMJE | Prescient Therapeutics, Ltd. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Prescient Therapeutics, Ltd. | |||
Verification Date | September 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |