Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04174716
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Idience Co., Ltd.

Tracking Information
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
 (submitted: November 21, 2019)
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).
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Homologous Recombination Repair Gene Mutation
  • Homologous Recombination Deficiency
Intervention  ICMJE Drug: IDX-1197
Until progression or unacceptable toxicity develops
Study Arms  ICMJE Experimental: IDX-1197
Patient will be receive IDX-1197HCl once daily for 28 continuous days
Intervention: Drug: IDX-1197
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2020)
310
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Won Sik Lee 82-2-526-3612 wonsiklee@idience.com
Contact: Minju Hong 82-2-526-3644 minju.hong@idience.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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