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Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS) (VASTUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04174716
Recruitment Status : Active, not recruiting
First Posted : November 22, 2019
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Idience Co., Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Solid Tumors Homologous Recombination Repair Gene Mutation Homologous Recombination Deficiency Drug: IDX-1197 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Phase 1b/2a Basket Trial of IDX-1197 in Patients With Homologous Recombination Repair Mutated Solid Tumors
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: IDX-1197
Patient will be receive IDX-1197HCl once daily for 28 continuous days
 Drug: IDX-1197
Until progression or unacceptable toxicity develops


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed cancers that have HRR mutation and are failed to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
  • Measurable disease according to RECIST, v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
  • Must have recovered from all side effects of their most recent systemic or local treatment (<CTCAE grade 3)
  • Life expectancy greater than 12weeks

Exclusion Criteria:

  • Prior treatment with PARP inhibitors
  • Symptomatic CNS metastases
  • History of or known carcinomatous meningitis
  • Concurrent administration of any anti-cancer therapies other than those administered in this study
  • Pregnant or lactating women
  • Refractory nausea and vomiting, malabsorption, total gastrectomy, external biliary shunt or significant bowel resection that would preclude adequate absorption.
  • Uncontrolled medical illness (such as infection requiring treatment with intravenous antibiotics)
  • Severe or unstable angina, myocardial infarction or ischemia requiring coronary artery bypass graft or stent within the previous 6 months, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment or New York Heart Association (NYHA) Class II to IV heart disease.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
  • Known hypersensitivity to IDX-1197 or any of the excipients of the product
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174716


Locations
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Sponsors and Collaborators
Idience Co., Ltd.
More Information
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Responsible Party: Idience Co., Ltd.
ClinicalTrials.gov Identifier: NCT04174716    
Other Study ID Numbers: ID-VDP-102
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Idience Co., Ltd.:
HRR
1197
venadaparib
IDX-1197
Additional relevant MeSH terms:
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Neoplasms