Biliary Tract CancerPhase 2/3NCT05065957
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
A Phase 2/3 study testing D07001-softgel capsules + Xeloda (or TS-1) and mFOLFOX in people with Biliary Tract Cancer, run by InnoPharmax Inc. at 5 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- D07001-softgel capsules + Xeloda (or TS-1) and mFOLFOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesTaiwan
- Study dates
- 29 Mar 2022to 31 Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
China Medical University Hospital
Taichung, 404
National Taiwan University Cancer Center
Taipei
National Taiwan University Hospotal
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: 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
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).
Read the detailed description
This open label, multicenter study will be conducted in 2 stages: a dose-finding stage (Phase IIa) and a dose-expansion stage (Phase IIb/III).
In phase IIa, eligible patients will be assigned to receive oral D07001-softgel on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle (9 doses per cycle) and Xeloda (or TS-1) twice daily on Day 1-14 of a 21-day cycle.
A modified 3+3 dose-finding design method will be applied to identify dose-limiting toxicities (DLTs) and establish the selected dose of D07001-softgel capsules plus Xeloda (or TS-1).
In phase IIb/III,the first 40 subjects (20 subjects per arm) will be randomly allocated in a 1:1 ratio in two arms. Arm A will receive active symptom control (ASC) with the selected dose from dose-finding stage of D07001-softgel capsules and Xeloda (or TS-1), in 21-day cycles. In arm B, subjects will receive ASC with mFOLFOX treatment. After the last subject of first 40 subjects will be completed the visit in the end of treatment, an adaptive interim analysis will be planned to re-estimate the required sample size based on the result of DCR if needed. The sponsor team will determine whether the study will be continued or stopped for futility.
If the study continues to proceed, the total subject number will be based on the decision from the results of interim study. The rest of subjects will be randomized to receive the combination of study drug or active-control drug with the same allocation in two arms. Both groups will continue the therapy until disease progression, withdrawn consent, or when another treatment discontinuation criterion is met.
- Conditions
- Biliary Tract Cancer
- Being tested
- D07001-softgel capsules + Xeloda (or TS-1), mFOLFOX
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D07001-softgel capsules + Xeloda (or TS-1)Drug
Also called Treatment group
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)
mFOLFOXDrug
Also called Control group
intravenous infusion on Day 1 for 14-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Phase IIa:Dose-Finding Stage | Experimental | Level -5: 20 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1).
Level -4: 40 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1).
Level -3: 60 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1).
Level -2: 80 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1).
Level -1 (starting dose): 100 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1).
Level 1: 100 mg D07001-softgel capsules plus 800 mg/m^2 Xeloda (or 30/40/50 mg TS-1).
Level 2: 100 mg D07001-softgel capsules plus 1000 mg/m^2 Xeloda (or 40/50/60 mg TS-1). Receives: Drug: D07001-softgel capsules + Xeloda (or TS-1) |
| Phase IIb/III: Dose Expansion Stage | Active comparator | ASC+ D07001-softgel capsules plus Xeloda (or TS-1)
ASC+mFOLFOX (5-FU+Oxalipatin+folinic acid) Receives: Drug: D07001-softgel capsules + Xeloda (or TS-1); Drug: mFOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date of informed consent to 30-day follow-up visit for each subject
To assess disease control rate (DCR)
To assess DCR, the percentage of treatment patients who achieved CR, PR, or SD.
Measured: 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 (5)
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
Measured: Cycle 1 Days 1, 8, and 12 (each cycle is 21 days)
Quality of life (QOL) will be assessed using the EORTC questionnaires
To access healthrelated quality of life of cancer patients participating in clinical trial.
Measured: Cycle 1 Days 1, and date of withdraw the study (assessed up to 24 months) for each subject (each cycle is 21 days)
To assess Progression-free survival (PFS)
To assess PFS, the time from treatment assignment/randomization until objective tumor progression or death
Measured: 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
To assess Objective response rate (ORR)
To assess ORR, the proportion of treated patients who achieved a BOR of CR or PR.
Measured: 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
To assess overall survival (OS)
To assess OS, the time from treatment assignment/randomization until death from any case
Measured: The survival follow-ups will follow every 6 weeks from date of discontinued study drug for up to 24 months till the death of the subject or closure of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start29 Mar 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: Dose-finding stage has been completed, and dose-expanding stage was not conducted due to design amendment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In phase IIa, a modified 3+3 dose-finding design trial will be conducted to identify the selected dose of the combination of D07001-softgel capsules plus Xeloda (or TS-1). After the dose-finding stage will be completed, a phase IIb/III adaptive design, open label, multicenter, active controlled, parallel-group trial will be implemented and incorporated into a dose-expansion stage to evaluate the efficacy and safety of D07001-softgel capsules plus Xeloda.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoPharmax Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, Ph.D, Principal investigator, National Institute of Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065957
- Sponsor's protocol ID
- Inno-GO-05
- Status last verified
- Nov 2026
- First submitted
- 7 Sep 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05065957
- Acronym / sponsor ID
- Inno-GO-05
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dose-finding stage has been completed, and dose-expanding stage was not conducted due to design amendment.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- InnoPharmax Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This open label, multicenter study will be conducted in 2 stages: a dose-finding stage (Phase IIa) and a dose-expansion stage (Phase IIb/III).
In phase IIa, eligible patients will be assigned to receive oral D07001-softgel on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle (9 doses per cycle) and Xeloda (or TS-1) twice daily on Day 1-14 of a 21-day cycle.
A modified 3+3 dose-finding design method will be applied to identify dose-limiting toxicities (DLTs) and establish the selected dose of D07001-softgel capsules plus Xeloda (or TS-1).
In phase IIb/III,the first 40 subjects (20 subjects per arm) will be randomly allocated in a 1:1 ratio in two arms. Arm A will receive active symptom control (ASC) with the selected dose from dose-finding stage of D07001-softgel capsules and Xeloda (or TS-1), in 21-day cycles. In arm B, subjects will receive ASC with mFOLFOX treatment. After the last subject of first 40 subjects will be completed the visit in the end of treatment, an adaptive interim analysis will be planned to re-estimate the required sample size based on the result of DCR if needed. The sponsor team will determine whether the study will be continued or stopped for futility.
If the study continues to proceed, the total subject number will be based on the decision from the results of interim study. The rest of subjects will be randomized to receive the combination of study drug or active-control drug with the same allocation in two arms. Both groups will continue the therapy until disease progression, withdrawn consent, or when another treatment discontinuation criterion is met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In phase IIa, a modified 3+3 dose-finding design trial will be conducted to identify the selected dose of the combination of D07001-softgel capsules plus Xeloda (or TS-1). After the dose-finding stage will be completed, a phase IIb/III adaptive design, open label, multicenter, active controlled, parallel-group trial will be implemented and incorporated into a dose-expansion stage to evaluate the efficacy and safety of D07001-softgel capsules plus Xeloda.
| Arm | Type | Receives |
|---|---|---|
| Phase IIa:Dose-Finding Stage | Experimental | Drug: D07001-softgel capsules + Xeloda (or TS-1)Level -5: 20 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1). Level -4: 40 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1). Level -3: 60 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1). Level -2: 80 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1). Level -1 (starting dose): 100 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg TS-1). Level 1: 100 mg D07001-softgel capsules plus 800 mg/m^2 Xeloda (or 30/40/50 mg TS-1). Level 2: 100 mg D07001-softgel capsules plus 1000 mg/m^2 Xeloda (or 40/50/60 mg TS-1). |
| Phase IIb/III: Dose Expansion Stage | Active comparator | Drug: D07001-softgel capsules + Xeloda (or TS-1), Drug: mFOLFOXASC+ D07001-softgel capsules plus Xeloda (or TS-1) ASC+mFOLFOX (5-FU+Oxalipatin+folinic acid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D07001-softgel capsules + Xeloda (or TS-1)Also: Treatment groupD07001-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) | Drug | Phase IIa:Dose-Finding Stage, Phase IIb/III: Dose Expansion Stage |
| mFOLFOXAlso: Control groupintravenous infusion on Day 1 for 14-day cycle | Drug | Phase IIb/III: Dose Expansion Stage |
Primary outcome
Incidence of adverse events (AEs)/ serious adverse event (SAEs)
Time frame: From date of informed consent to 30-day follow-up visit for each subject
AEs will be assessed via the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
To assess disease control rate (DCR)
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
To assess DCR, the percentage of treatment patients who achieved CR, PR, or SD.
5 secondary outcomes
Phase IIa and IIb: Pharmacokinetics (PK) of gemcitabine (dFdC), difluorodeoxyuridine (dFdU), capecitabine, 5-FU, Tegafur, Gimeracil, and Oteracil potassium
Time frame: Cycle 1 Days 1, 8, and 12 (each cycle is 21 days)
Quality of life (QOL) will be assessed using the EORTC questionnaires
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)
To assess Progression-free survival (PFS)
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
To assess Objective response rate (ORR)
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
To assess overall survival (OS)
Time frame: The survival follow-ups will follow every 6 weeks from date of discontinued study drug for up to 24 months till the death of the subject or closure of the study.
Results and safety
The study was stopped early (reason given: Dose-finding stage has been completed, and dose-expanding stage was not conducted due to design amendment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzong Chen, Ph.D principal investigator
National Institute of Cancer Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing D07001-softgel capsules + Xeloda (or TS-1) and mFOLFOX in people with Biliary Tract Cancer, run by InnoPharmax Inc. at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Dose-finding stage has been completed, and dose-expanding stage was not conducted due to design amendment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs)/ serious adverse event (SAEs) (time frame: From date of informed consent to 30-day follow-up visit for each subject). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.