RecruitingPhase 2Phase 3NCT05065957

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

Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure

Sponsor

InnoPharmax Inc.

Enrollment

180 participants

Start Date

Mar 29, 2022

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer

Summary

The primary objective are: To assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda/TS-1. To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as assessed by disease control rate (DCR).

Eligibility

Min Age: 18 Years

Inclusion Criteria23

Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan)
Histopathological or cytologic diagnosis of unresectable metastatic or locally advanced BTC (cholangiocarcinoma, gallbladder cancer or ampullary carcinoma)
Subject must have failed from first line gemcitabine and cisplatin-based chemotherapy
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
Life expectancy is >12 weeks
Adequate bone marrow function, demonstrated by:
Absolute neutrophil count (ANC) ≥1,500 cell/mm3
Platelet count ≥ 100,000 cells/mm3
Hemoglobin ≥ 9 g/dL
Adequate liver function, demonstrated by:
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
Total bilirubin ≤1.5 x ULN
Albumin ≥3.0 g/dL
International normalized ratio (INR) <1.5
Adequate renal function, demonstrated by:
Serum creatinine ≤1.5 x ULN
Creatinine clearance ≥ 50mL/min calculated by Cockcroft-Gault formula or eGFR ≥ 50mL/min/1.73m2 by 2021 CKD-EPI Creatinine Equation
A negative serum pregnancy test at screening and is not breastfeeding in woman of childbearing potential
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.
Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures
Subject is willing to comply with protocol-required visit schedule and visit requirements
No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment
Subject has not received other chemotherapy since first-line treatment

Exclusion Criteria22

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.
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
Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance
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.
Prior discontinuation of fluoropyrimidine because of any unexpected or severe reaction.
Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of enrollment.
Under flucytosine treatment.
Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted)
Any GI disorder which would significantly impede absorption of an oral agent
Known brain or leptomeningeal metastases
Major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days
Any active disease or condition that would not permit compliance with the protocol
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
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.
Have a seizure disorder not controlled on medication (based on decision of Investigator)
Received an investigational agent within 28 days of enrollment
Have an uncontrolled active viral, bacterial, or systemic fungal infection
Known human immunodeficiency virus (HIV) infection
Have HBsAg (hepatitis B surface antigen) positive with HBV-DNA ≥2000 copies/ml and/or anti-HCV antibody (HCV) positive with HCV-RNA positive.
Received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening
History of drug or alcohol abuse within last year
Have any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial

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Interventions

DRUGD07001-softgel capsules + Xeloda (or TS-1)

D07001-softgel capsules: 3 times per week (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle, 9 doses per cycle). Xeloda (or TS-1): twice daily for 14 consecutive days followed by 7 days rest (1 treatment cycle)

DRUGmFOLFOX

intravenous infusion on Day 1 for 14-day cycle