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D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer

ConditionBiliary Tract Cancer (BTC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnoPharmax Inc.

About this trial

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. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • D07001-Softgel Capsules

    Drug

    D07001-softgel capsule is an oral gemcitabine.

  • Placebo

    Drug

    Placebo has the same excipient with D07001-softgel but without active pharmaceutical ingredients (APIs)

  • Capecitabine

    Combination product

    Capecitabine, a fluoropyrimidine carbamate derivative, is an oral tumor activator and selective cytotoxic agent.

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: D07001-Softgel Capsules 60 mg + CapecitabineExperimental treatment 2 interventions
Group B: D07001-Softgel Capsules 100 mg + CapecitabineExperimental treatment 2 interventions
Group C: Placebo + CapecitabinePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

To assess the over survival (OS) of 2 doses of D07001-softgel capsules + capecitabine compared with placebo + capecitabine

Time frame
From date of randomization until the date of death, assessed up to 2 years

Secondary outcomes

1

progression-free survival (PFS)

To assess the progression-free survival (PFS) of D07001-softgel capsules + capecitabine compared with placebo + capecitabine

Time frame
From randomization to death or progression disease, assessed up to 2 years
2

6-month survival rate

To assess the 6-month OS of D07001-softgel capsules + capecitabine compared with placebo + capecitabine

Time frame
Assessed as the time at 6 month timepoint from randomization
3

overall response rate (ORR)

To assess the overall response rate (ORR) of D07001-softgel capsules + capecitabine

Time frame
From treatment starting until end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).
4

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

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

Time frame
Assessed as the time from randomization to end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).

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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