RECRUITING

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

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Conditions

Gastric Cancer1197IDX-1197venadaparib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, Phase 1b/2a 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.

Official Title

An Open-Label, International, Multicenter, Phase 1b/2a 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

Quick Facts

Study Start:2021-06-28
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04725994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach.
  2. * 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.
  3. * 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.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  5. * Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening.
  1. * Symptomatic central nervous system or uncontrolled brain metastasis
  2. * Carcinomatous meningitis or its history.
  3. * For Group 1, patients who are HER 2 positive.
  4. * 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.
  5. * 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.
  6. * Uncontrolled hypertension
  7. * Immunocompromised patients, such as patients known to be serologically positive for HIV.
  8. * Patients with known active Hepatitis B or C infection.
  9. * Patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids.
  10. * Diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics.
  11. * Any unresolved clinically significant Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity
  12. * 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.
  13. * Current use of a cytochrome P3A4 inhibitor or inducer and strong uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1) inhibitors.

Contacts and Locations

Study Contact

Won Sik Lee
CONTACT
8225263622
wonsiklee@idience.com
Minju Hong
CONTACT
8225263644
minju.hong@idience.com

Study Locations (Sites)

USC Norris Comp. Cancer Ctr Hospital
Los Angeles, California, 90033
United States
Hematology Oncology Clinic Baton Rouge / Sarah Cannon
Baton Rouge, Louisiana, 70809
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Astera Cancer Care
East Brunswick, New Jersey, 08816
United States

Collaborators and Investigators

Sponsor: Idience Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-28
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-06-28
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • 1197
  • IDX-1197
  • venadaparib

Additional Relevant MeSH Terms

  • Gastric Cancer