Study on D07001 Softgel Capsules and Capecitabine for Advanced Biliary Tract Cancer

Sponsor: InnoPharmax Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06622057

Provider View

This clinical trial is testing a new treatment using D07001 softgel capsules combined with capecitabine to see if it can improve survival in patients with advanced biliary tract cancer. Participants will be randomly assigned to receive either the new treatment or a placebo, along with capecitabine.

Patient Parameters

Program Overview

The aim of this study is to find out if D07001 softgel capsules, when taken with capecitabine, can help patients with advanced biliary tract cancer live longer compared to taking a placebo with capecitabine. Patients will be randomly placed into one of three groups: one group will receive 60 mg of D07001, another will receive 100 mg of D07001, and the third will receive a placebo. All groups will also take capecitabine. Treatment will continue until the cancer worsens, the patient decides to stop, or after completing 12 cycles of treatment.

Description

This is a Phase III study, meaning it is in the later stages of testing. It involves patients with advanced biliary tract cancer who have not responded to previous treatments like gemcitabine and cisplatin, or have refused or not responded to other chemotherapy options like FOLFOX or irinotecan with fluorouracil. About 195 patients will participate, divided into three groups. Each group will receive either 60 mg or 100 mg of D07001 softgel capsules, or a placebo, along with capecitabine tablets. The study will monitor patients for disease progression, side effects, and overall survival. Participants will continue treatment until they experience unacceptable side effects, the cancer progresses, they choose to stop, or they complete 12 treatment cycles. Follow-up visits will occur by phone every month and one year after the end of treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and agree to follow study requirements.
  • Aged 18 years or older.
  • Diagnosed with advanced biliary tract cancer that cannot be surgically removed.
  • Cancer must be measurable by scans.
  • Must have tried and not responded to previous chemotherapy treatments.
  • May have specific genetic markers that allow participation even without prior FOLFOX treatment.
  • Must be in good general health with a performance status of 0-2.
  • Life expectancy of at least 12 weeks.
  • Must have adequate blood, liver, and kidney function as shown by specific tests.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Men must agree to use contraception and not donate sperm during and after the study.
  • Must be willing to attend all study visits and follow the treatment plan.
  • Must have completed previous cancer treatments at least 14 days before joining the study.

Exclusion Criteria

  • Have another active cancer within the past 2 years, except for certain skin or cervical cancers.
  • Stopped previous treatments due to severe side effects.
  • Have had severe reactions to similar medications.
  • Currently taking certain medications that interfere with the study drugs.
  • Have unresolved side effects from previous treatments.
  • Have digestive issues that affect medication absorption.
  • Have brain or spinal cord cancer spread.
  • Have had major surgery or radiation recently.
  • Have serious health conditions that prevent following the study.
  • Have significant heart disease or uncontrolled seizures.
  • Have active infections or certain viral infections.
  • Have received a live vaccine recently.
  • Have a history of substance abuse within the past year.
  • Have any other serious medical condition that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
University Hospital Cleveland Medical Center44106ClevelandOhio

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