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New treatment option for Biliary Tract Cancer (BTC)
Official title D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT06622057
What this study is testing
What is D07001-Softgel Capsules?
D07001-Softgel Capsules is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for biliary tract cancer (btc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS). Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
- Participant aged at least 18 years at the time of consent.
- Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer...
- Participant has measurable disease as assessed by central review by RECIST v1.1.
- Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an immune checkpoint inhibitor, such as...
You likely can't join if
- Participant has a diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of...
- Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or...
- Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.
- Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.
- Participant is currently receiving flucytosine treatment.
- Participant has residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted).
See the full eligibility criteria
Who can join
- Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
- Participant aged at least 18 years at the time of consent.
- Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).
- Participant has measurable disease as assessed by central review by RECIST v1.1.
- Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an immune checkpoint inhibitor, such as durvalumab or pembrolizumab, or S-1 (tegafur, gimeracil, and oteracil...
- Participants with tumors expressing the following biomarkers may be enrolled even if they have not previously received FOLFOX but have received appropriate targeted therapies until disease progression or intolerance...
- Participant has ECOG PS of 0-2.
- Participant's life expectancy is ≥12 weeks.
- Participant has adequate bone marrow function, demonstrated by:
- Absolute neutrophil count ≥1500 cell/mm3.
- Platelet count ≥85,000 cells/mm3.
- Hemoglobin ≥9 g/dL.
- Participant has adequate liver function, demonstrated by:
- Aspartate transaminase and alanine transaminase ≤2.5 × upper limit of normal (ULN), or ≤5.0 × ULN in the case of liver lesions.
- Total bilirubin ≤1.5 × ULN.
- Albumin ≥3.0 g/dL.
- International normalized ratio \<1.5.
- Participant has adequate renal function, demonstrated by creatinine clearance ≥ 45 mL/min calculated by Cockcroft-Gault formula or estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 by the 2021 Chronic Kidney...
- No clinically significant abnormalities in coagulation results.
- Participant is eligible to participate if not pregnant (as demonstrated by serum pregnancy testing at Screening), not breastfeeding, and at least 1 of the following conditions applies:
- Not of childbearing potential (CBP). Participants of non-childbearing potential are defined as those with functioning ovaries with a documented history of tubal ligation or hysterectomy or who are postmenopausal, as...
- A participant of CBP who is sexually active with a partner who could impregnate them agrees to use a highly effective form of contraception during the study and for at least 6 months after the EOS intervention.
- Participants with partners of childbearing potential whom they could impregnate must agree to use contraception during the study and for 3 months after the EOS intervention.
- Participants who are able to donate sperm must refrain from sperm donation during the study and for 3 months after the EOS intervention.
- Participant is willing to comply with the protocol-required visit schedule and visit requirements.
- More than 14 days have elapsed between the participant completing a prior line of chemotherapy or targeted therapy, and enrollment. More than 28 days have elapsed between the participant receiving concurrent...
What rules you out
- Participant has a 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.
- Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or intolerance.
- Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.
- Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.
- Participant is currently receiving flucytosine treatment.
- Participant has residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted).
- Participant has any gastrointestinal disorder or prior gastrointestinal surgery that would significantly impede absorption of an oral agent, such as gastrectomy, Crohn's disease, ulcerative colitis, or short gut...
- Participant has known brain or leptomeningeal metastases.
- Participant had major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days.
- Participant has any active disease or condition that would not permit compliance with the protocol.
- Participant has clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, New York Heart Association Grade 2 or greater), or uncontrolled serious cardiac...
- Participant has documented cerebrovascular disease.
- Participant has a seizure disorder not controlled with medication (based on Investigator's decision).
- Participant has received an investigational agent within 28 days of enrollment.
- Participant has an uncontrolled active viral, bacterial, or systemic fungal infection.
- Participants with positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus antibody (anti-HCV) and detectable hepatitis B virus (HBV) DNA ≥2000 copies/mL or hepatitis C virus (HCV) RNA above the...
- Has positive human immunodeficiency virus antibody.
- Participant has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks before Screening.
- Participant has a history of drug or alcohol abuse within the year before signing the informed consent form.
- Participant has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in or compliance with the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Miami Beach, Florida, United States
- Cleveland, Ohio, United States
- Kaohsiung City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Beach, Florida, United States; Cleveland, Ohio, United States; Kaohsiung City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.