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

ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnoPharmax Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • D07001-softgel capsules + Xeloda (or TS-1)

    Drug

    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)

  • mFOLFOX

    Drug

    intravenous infusion on Day 1 for 14-day cycle

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Phase IIa:Dose-Finding StageExperimental treatment 1 intervention
Group B: Phase IIb/III: Dose Expansion StageActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)/ serious adverse event (SAEs)

AEs will be assessed via the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Time frame
From date of informed consent to 30-day follow-up visit for each subject
2

To assess disease control rate (DCR)

To assess DCR, the percentage of treatment patients who achieved CR, PR, or SD.

Time frame
From date of randomization until the date of first documented progression, date of death from any cause, or date of withdraw the study for each subject, whichever came first, assessed up to 24 months

Secondary outcomes

1

Phase IIa and IIb: Pharmacokinetics (PK) of gemcitabine (dFdC), difluorodeoxyuridine (dFdU), capecitabine, 5-FU, Tegafur, Gimeracil, and Oteracil potassium

PK parameters (Peak Plasma Concentration (Cmax)) of gemcitabine and Xeloda or TS-1 will be evaluated

Time frame
Cycle 1 Days 1, 8, and 12 (each cycle is 21 days)
2

Quality of life (QOL) will be assessed using the EORTC questionnaires

To access healthrelated quality of life of cancer patients participating in clinical trial.

Time frame
Cycle 1 Days 1, and date of withdraw the study (assessed up to 24 months) for each subject (each cycle is 21 days)
3

To assess Progression-free survival (PFS)

To assess PFS, the time from treatment assignment/randomization until objective tumor progression or death

Time frame
From date of randomization until the date of first documented progression, date of death from any cause, or date of withdraw the study for each subject, whichever came first, assessed up to 24 months
4

To assess Objective response rate (ORR)

To assess ORR, the proportion of treated patients who achieved a BOR of CR or PR.

Time frame
From date of randomization until the date of first documented progression, date of death from any cause, or date of withdraw the study for each subject, whichever came first, assessed up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InnoPharmax Inc.

Lead sponsor

Source ClinicalTrials.gov
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