Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS) (VASTUS)
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ClinicalTrials.gov Identifier: NCT04174716 |
Recruitment Status :
Recruiting
First Posted : November 22, 2019
Last Update Posted : February 26, 2021
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Sponsor:
Idience Co., Ltd.
Information provided by (Responsible Party):
Idience Co., Ltd.
Tracking Information | |||||||||
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First Submitted Date ICMJE | November 18, 2019 | ||||||||
First Posted Date ICMJE | November 22, 2019 | ||||||||
Last Update Posted Date | February 26, 2021 | ||||||||
Actual Study Start Date ICMJE | November 6, 2019 | ||||||||
Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
objective response rate (ORR) [ Time Frame: Up to 24 weeks ] Confirmed objective response rate (ORR) determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS) | ||||||||
Official Title ICMJE | An Open-label, Multi-center, Phase 1b/2a Basket Trial of IDX-1197 in Patients With Homologous Recombination Repair Mutated Solid Tumors | ||||||||
Brief Summary | This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation. There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D. |
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Detailed Description | Not Provided | ||||||||
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 |
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Intervention ICMJE | Drug: IDX-1197
Until progression or unacceptable toxicity develops
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Study Arms ICMJE | Experimental: IDX-1197
Patient will be receive IDX-1197HCl once daily for 28 continuous days
Intervention: Drug: IDX-1197
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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 |
310 | ||||||||
Original Estimated Enrollment ICMJE |
420 | ||||||||
Estimated Study Completion Date ICMJE | March 31, 2023 | ||||||||
Estimated Primary Completion Date | September 30, 2021 (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 | 19 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Korea, Republic of | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04174716 | ||||||||
Other Study ID Numbers ICMJE | ID-VDP-102 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Idience Co., Ltd. | ||||||||
Study Sponsor ICMJE | Idience Co., Ltd. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Idience Co., Ltd. | ||||||||
Verification Date | January 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |