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 :
Active, not recruiting
First Posted : November 22, 2019
Last Update Posted : March 1, 2023
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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 | March 1, 2023 | ||||
Actual Study Start Date ICMJE | November 6, 2019 | ||||
Estimated Primary Completion Date | December 31, 2023 (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 | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
310 | ||||
Original Estimated Enrollment ICMJE |
420 | ||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||
Estimated Primary Completion Date | December 31, 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 | 19 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 | 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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Current Responsible Party | Idience Co., Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Idience Co., Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Idience Co., Ltd. | ||||
Verification Date | February 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |