Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP® (PREDICT 2X-121)
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ClinicalTrials.gov Identifier: NCT03878849 |
Recruitment Status :
Recruiting
First Posted : March 18, 2019
Last Update Posted : March 13, 2023
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Sponsor:
Allarity Therapeutics
Collaborators:
Alcedis GmbH
Amarex Clinical Research
Information provided by (Responsible Party):
Allarity Therapeutics
Tracking Information | |||||||||
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First Submitted Date ICMJE | March 8, 2019 | ||||||||
First Posted Date ICMJE | March 18, 2019 | ||||||||
Last Update Posted Date | March 13, 2023 | ||||||||
Actual Study Start Date ICMJE | April 15, 2019 | ||||||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Objective response rate (ORR) [ Time Frame: evaluated after up to approximately 2 years ] defined as complete response (CR) or partial response (PR) using the RECIST criteria version 1.1
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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 | Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP® | ||||||||
Official Title ICMJE | Phase II, Prospective Open Label, Single Arm Study to Investigate Anti-tumor Effect and Tolerability of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP® | ||||||||
Brief Summary | This study is to be performed as an open label, multicenter, single arm study of 2X-121 to evaluate anti-tumor efficacy of 2X-121 as single agent therapy in a 28-days cycle in advanced ovarian cancer patients. 2X-121 will be supplied for oral administration once daily as 600 mg (3 x 200 mg) capsules in a 28 days cycle. Patients with predicted high likelihood of responding to the drug (2X-121) using drug response prediction (DRP®), will be included in the study. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Ovarian Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 2X-121
Oral administration of 2X-121 once daily as 600 mg hard gelatin capsules in a 28 days cycle.
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 | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 2024 | ||||||||
Estimated Primary Completion Date | September 2023 (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 |
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Listed Location Countries ICMJE | United Kingdom, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03878849 | ||||||||
Other Study ID Numbers ICMJE | (PARPi) 2X-1002 2020-000539-31 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Allarity Therapeutics | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Allarity Therapeutics | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||
PRS Account | Allarity Therapeutics | ||||||||
Verification Date | March 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |