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Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer

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: NCT04725994
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Idience Co., Ltd.

Study Description
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Brief Summary:
This is an open-label, Phase 1b study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: IDX-1197+XELOX Drug: IDX-1197+Irinotecan Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, International, Multicenter, Phase 1b Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients With Advanced Gastric Cancer
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Group 1 Drug: IDX-1197+XELOX
The dose levels will be escalated following a 3+3 dose escalation scheme.
Group 2 Drug: IDX-1197+Irinotecan
The dose levels will be escalated following a 3+3 dose escalation scheme.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [ Time Frame: through study completion (Up to 12 months) ]
    To determine the MTD and RP2D of IDX-1197 when given in combination with XELOX or Irinotecan. This will be accomplished by the standard 3+3 dose escalation design. If 2 of the 3 to 6 patients in a particular dose level experience a DLT, the dose escalation should be stopped at this dose level, and the MTD will be determined.

  2. Dose Limiting Toxicities (DLTs) [ Time Frame: during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2 ]
    Occurrence of DLTs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach.
  • Group 2, patients with recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach, who were treated ≥2 times with palliative chemotherapy before screening.
  • At least 1 evaluable lesion for the dose escalation part and at least 1 measurable lesion according to RECIST v1.1 for the dose expansion part.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

Exclusion Criteria:

  • Symptomatic central nervous system or uncontrolled brain metastasis
  • Carcinomatous meningitis or its history.
  • For Group 1, patients who are HER 2 positive.
  • Any other concurrent uncontrolled illness including, but not limited to, active or ongoing symptomatic infection requiring IV antibiotic treatment, uncontrolled diabetes, hepatic, renal, or respiratory illness.
  • Severe or unstable angina, myocardial infarction or ischemia, symptomatic congestive heart failure, arterial or venous thromboembolism requiring coronary artery bypass graft or stent within the past 6 months or clinically significant cardiac dysrhythmia or New York Heart Association class II ~ IV heart disease within 6 months of randomization.
  • Uncontrolled hypertension
  • Immunocompromised patients, such as patients known to be serologically positive for HIV.
  • Patients with known active Hepatitis B or C infection.
  • Patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids.
  • Diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics.
  • Any unresolved clinically significant Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity
  • Resting ECG with measurable QTcF > 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome.
  • Current use of a cytochrome P3A4 inhibitor or inducer and strong uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1) inhibitors.
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): NCT04725994


Contacts
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Contact: Won Sik Lee 82-2-526-3612 wonsiklee@idience.com
Contact: Minju Hong 82-2-526-3644 minju.hong@idience.com

Locations
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United States, California
USC Norris Comp. Cancer Ctr Hospital Recruiting
Los Angeles, California, United States, 90033
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
United States, Louisiana
Hematology Oncology Clinic Baton Rouge / Sarah Cannon Not yet recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
China
Beijing Cancer Hospital Not yet recruiting
Beijing, China
The Sixth Affiliated Hospital of Sun Yat-Sen University Not yet recruiting
Guangzhou, China
Shanghai East Hospital Not yet recruiting
Shanghai, China
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Severance Hospital - Yonsei Cancer Center Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Idience Co., Ltd.
More Information
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Responsible Party: Idience Co., Ltd.
ClinicalTrials.gov Identifier: NCT04725994    
Other Study ID Numbers: ID-VDP-103
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Idience Co., Ltd.:
1197
IDX-1197
venadaparib
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Stomach Diseases
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents