Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer

Launched by INNOPHARMAX INC. · Sep 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced biliary tract cancer, which includes types of cancer like cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma. The researchers want to find out if combining D07001 softgel capsules with the drugs Xeloda or TS-1 is safe and effective for patients who have not responded to their first-line chemotherapy treatment with gemcitabine and cisplatin. The trial is currently recruiting participants who are at least 18 years old, have specific health conditions, and meet certain health criteria, including having a life expectancy of more than 12 weeks and good overall health.

If you choose to participate, you will closely monitor your health and side effects from the treatment during regular visits. The study will help doctors understand how well this combination works to control the disease. It’s important to know that participants must be willing to follow the study rules and have not received other chemotherapy since their last treatment. Overall, this trial aims to explore new options for those facing a challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan)
• • 2. Histopathological or cytologic diagnosis of unresectable metastatic or locally advanced BTC (cholangiocarcinoma, gallbladder cancer or ampullary carcinoma)
• • 3. Subject must have failed from first line gemcitabine and cisplatin-based chemotherapy
• • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
• • 5. Life expectancy is \>12 weeks
• 6. Adequate bone marrow function, demonstrated by:
• • 1. Absolute neutrophil count (ANC) ≥1,500 cell/mm3
• • 2. Platelet count ≥ 100,000 cells/mm3
• • 3. Hemoglobin ≥ 9 g/dL
• 7. Adequate liver function, demonstrated by:
• • 1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases
• • 2. Total bilirubin ≤1.5 x ULN
• • 3. Albumin ≥3.0 g/dL
• • 4. International normalized ratio (INR) \<1.5
• 8. Adequate renal function, demonstrated by:
• • 1. Serum creatinine ≤1.5 x ULN
• • 2. Creatinine clearance ≥ 50mL/min calculated by Cockcroft-Gault formula or eGFR ≥ 50mL/min/1.73m2 by 2021 CKD-EPI Creatinine Equation
• • 9. A negative serum pregnancy test at screening and is not breastfeeding in woman of childbearing potential
• • 10. Women of childbearing potential or male subjects must use a medically acceptable form of contraception as 2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device), hormonal contraception (estrogen or progesterone agents) or 1 barrier method in combination with spermicide. Birth control is required 1 month prior to screening, for the duration of their study participation, and for 1 month after the end of the study; female partners of male subjects must adhere to the same birth control methods.
• • 11. Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures
• • 12. Subject is willing to comply with protocol-required visit schedule and visit requirements
• • 13. No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment
• • 14. Subject has not received other chemotherapy since first-line treatment
• Exclusion Criteria:
• • 1. Have prior chemotherapy regimen other than first line gemcitabine and cisplatin-based therapy for unresectable metastatic or locally advanced BTC Note: prior fluoropyrimidine base (including capecitabine, carmofur (HCFU), doxifluridine, fluorouracil (5-FU), and tegafur) chemotherapy (including fluoropyrimidine monotherapy or combination therapy) are allowed as postsurgical adjuvant therapy.
• • 2. Diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent
• • 3. Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance
• • 4. Known or suspected hypersensitivity to capecitabine, tegafur, gimeracil, oteracil potassium, oxaliplatin or other platinum compounds, leucovorin products, folic acid or folinic acid, 5-fluorouracil or their excipients.
• • 5. Prior discontinuation of fluoropyrimidine because of any unexpected or severe reaction.
• • 6. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of enrollment.
• • 7. Under flucytosine treatment.
• • 8. Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted)
• • 9. Any GI disorder which would significantly impede absorption of an oral agent
• • 10. Known brain or leptomeningeal metastases
• • 11. Major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days
• • 12. Any active disease or condition that would not permit compliance with the protocol
• • 13. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association \[NYHA\] Grade 2 or greater), or uncontrolled serious cardiac arrhythmia
• • 14. Have documented cerebrovascular disease. Subjects with the disease may be excluded, but if the investigator assesses that they are asymptomatic or well controlled could be enrolled.
• • 15. Have a seizure disorder not controlled on medication (based on decision of Investigator)
• • 16. Received an investigational agent within 28 days of enrollment
• • 17. Have an uncontrolled active viral, bacterial, or systemic fungal infection
• • 18. Known human immunodeficiency virus (HIV) infection
• • 19. Have HBsAg (hepatitis B surface antigen) positive with HBV-DNA ≥2000 copies/ml and/or anti-HCV antibody (HCV) positive with HCV-RNA positive.
• • 20. Received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening
• • 21. History of drug or alcohol abuse within last year
• • 22. Have any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial