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Gastrointestinal CancerPhase 1/2NCT03531320

Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase

A Phase 1/2 study testing D07001-softgel capsules in people with Gastrointestinal Cancer and Biliary Tract Cancer, run by InnoPharmax Inc. at 4 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI) cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Cancer, Biliary Tract Cancer
What is being tested?
D07001-softgel capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
4 sitesTaiwan
Study dates
6 Aug 2018to 29 Dec 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures
  • 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 GI cancer (Part 1) or unresectable metastatic or locally advanced BTC (cholangiocarcinoma or gallbladder cancer; Part 2)
  • Part 1 only: Refractory to or have relapsed from all standard therapies of advanced GI malignancy
  • Part 2 only:
  • Achieved stable disease or better, based on the Investigator's assessment, in response to first line systemic therapy or CCRT, with continued stable disease or better based on imaging studies obtained as part of screening
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  • Completed first line systemic therapy (with 2-8 cycles of chemotherapy with a gemcitabine based regimen) or CCRT, based on the local standard of care and preferences in the participating countries Note: No more than 30% of patients enrolled in Part 2 will have received CCRT
  • No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment
  • Part 2 only: Patient has not received intervening systemic therapy since first line treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 in Part 1 and 0-1 in Part 2
  • 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 ≥ 60 mL/min calculated by Cockcroft-Gault formula or directly measured with 24 hr urine collection
  • If a woman of childbearing potential, the patient has a negative serum pregnancy test at screening and is not breastfeeding
  • If a woman of childbearing potential, patient 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 patients must adhere to the same birth control methods.
  • Patient is willing to comply with protocol-required visit schedule and visit requirements

Who cannot join

  • Part 2 only: More than one prior chemotherapy regimen for unresectable metastatic or locally advanced BTC Note: prior radiation (with or without radiosensitizing doses of chemotherapy) or fluoropyrimidine chemotherapy are allowed as postsurgical adjuvant therapy.
  • Part 2 only: Received any systemic therapy (chemotherapy, biologics, immunotherapy, or investigational agents) for metastatic disease other than gemcitabine based chemotherapy or CCRT for locally advanced BTC
  • Diagnosis of active malignancy (other than GI cancer [Part 1] or BTC [Part 2]) 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
  • Any GI disorder which would significantly impede absorption of an oral agent
  • Known brain or leptomeningeal metastases
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  • Surgery or radiation therapy within the past 28 days
  • Part 2 only: Evidence of disease progression, based on the Investigator's assessment, on the screening computed tomography (CT) scan or magnetic resonance imaging (MRI) scan
  • Any active disease or condition that would not permit compliance with the protocol
  • Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted)
  • 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
  • Patient has a history of drug or alcohol abuse within last year
  • Patient has documented cerebrovascular disease
  • Patient has a seizure disorder not controlled on medication (based on decision of Investigator)
  • Patient received an investigational agent within 28 days of enrollment
  • Patients with uncontrolled active viral, bacterial, or systemic fungal infection
  • Patient has known human immunodeficiency virus (HIV) infection
  • Patient has hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical history. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and the Clinical Research Organization (CRO) Medical Monitor
  • Patient has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening
  • Patient has 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

4 sites in 1 country.

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 404

  • National Cheng-Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: Open-Label, Multicenter Study of D07001-Softgel Capsules (Oral Gemcitabine Hydrochloride) in Subjects With Unresectable, Metastatic or Locally Advanced Gastrointestinal (GI) Cancer in Dose-Escalation Phase and in Subjects With Advanced Biliary Tract Cancer (BTC) Following Primary Chemotherapy or Combined Chemoradiotherapy (CCRT) in Dose-Expansion Phase

Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI) cancer.

Part 2: Dose-Expansion Phase (Phase 2) The primary objective is to assess the safety and tolerability of D07001 softgel in patients who have achieved stable disease or better following first line chemotherapy or combined chemoradiotherapy (CCRT) for unresectable metastatic or locally advanced biliary tract cancer (BTC)

Read the detailed description

This open label, multicenter study will be conducted in 2 parts: a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2).

In both Part 1 and Part 2, 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).

Part 1: Dose Escalation Phase (Phase 1b) Part 1 of the study will follow a 3+3 dose escalation scheme at predefined dose levels. There will be sequential cohorts of 3 to 6 patients each with increasing doses of 40 mg, 60 mg, 80 mg, 120 mg, and 160 mg per cohort. There will be no intra patient dose escalation. Cycle 1 (21 days) is defined as the dose limiting toxicity (DLT) assessment period.

Part 2: Dose Expansion Phase (Phase 2) In Part 2 of the study, eligible patients will be randomized in a 1:1 ratio to receive D07001-softgel in an open label manner at 1 of the 2 dose levels selected for expansion. Twenty (20) patients will be enrolled to each dose expansion cohort. Patients will be treated until withdrawal from treatment due to disease progression according to RECIST v1.1, withdrawn consent, or when another treatment discontinuation criterion is met. Patients who are discontinued from study drug for reasons other than disease progression or toxicity in the first 2 cycles of Part 2 will be replaced.

Being tested
D07001-softgel capsules
Medical subject headings
Gastrointestinal Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D07001-softgel capsulesDrug

    Active Ingredient:Gemcitabine hydrochloride

Study groups in NCT03531320
Study groupRoleWhat they receive
Part 1:Dose-Escalation PhaseExperimental40 mg D07001-softgel capsules 60 mg D07001-softgel capsules 80 mg D07001-softgel capsules 120 mg D07001-softgel capsules 160 mg D07001-softgel capsules
Receives: Drug: D07001-softgel capsules
Part 2: Dose-Expansion Phase (Phase 2)Experimentalhigher dose-expansion of D07001-softgel capsules lower dose-expansion of D07001-softgel capsules
Receives: Drug: D07001-softgel capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Establish the Maximum Tolerated Dose (MTD)

    MTD will be defined based on the number of dose limiting toxicities (DLT) in subjects at each dose level.

    DLT definition: In Part 1 of the study, any of the following AEs occurring during Cycle 1 will be classified as DLTs, if there is a reasonable possibility that it is related to the study drug

    • Hematologic:
    • Grade 4 neutropenia lasting >7 days
    • Febrile neutropenia (defined as neutropenia Grade ≥3 and a body temp ≥38.3°C)
    • Grade ≥3 neutropenic infection
    • Grade 4 anemia
    • Grade ≥3 thrombocytopenia with bleeding
    • Grade 4 thrombocytopenia
    • Non-hematologic:
    • Grade ≥3 toxicities that are considered clinically significant, except those that have not been maximally treated (e.g., nausea, vomiting, diarrhea*) or can be easily treated (e.g., electrolyte abnormalities).
    • Failure to deliver at least 6 of the planned 9 doses during Cycle 1 due to treatment-related toxicities.
    • Upon the second occurrence of a toxicity leading to a dose hold.

    Measured: During Cycle 1 of treatment (each cycle is 21 days) for each subject

  2. Part 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

    Measured: From date of informed consent to 30-day follow-up visit for each subject, an average of 10 months

  3. Part 2: Incidence of Dose Modifications, Including Dose Reduction, Interruption, or Discontinuation of Study Drug

    To measure ratio of total subjects who experienced the dose modifications including dose reduction, interruption, or discontinuation of study drug due to AEs.

    Measured: First dose through last dose for each subject, an average of 8 months

Secondary outcomes (4)

  1. Part 1: Pharmacokinetics (PK)- Cmax

    PK would be analyzed by maximum concentration (Cmax) of dFdC

    Measured: Cycle 1 Days 1 and 15

  2. Part 1: PK- AUC

    PK would be analyzed by Area Under Curve (AUC) of dFdC

    Measured: Cycle 1 Days 1 and 15

  3. Part 2: Pharmacokinetics (PK)- Cmax

    PK would be analyzed by maximum concentration (Cmax) of dFdC

    Measured: Cycle 1 Days 1, 8, and 15; Cycle 1 Day 15 and Cycle 2 Day 1 for food-effect cohort only

  4. Part 2: PK- AUC

    PK would be analyzed by Area Under Curve (AUC) of dFdC

    Measured: Cycle 1 Days 1, 8, and 15; Cycle 1 Day 15 and Cycle 2 Day 1 for food-effect cohort only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start6 Aug 2018
  3. Primary completion28 Dec 2020
  4. Study completion29 Dec 2020

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part 1 of the study comprises a sequential dose escalation to identify dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD), if any, of D07001-softgel in patients with unresectable locally advanced or metastatic GI cancer. Part 1 will follow a 3+3 dose escalation scheme at predefined dose levels. There will be sequential cohorts of 3 to 6 patients each with increasing doses of 40 mg, 60 mg, 80 mg, 120 mg, and 160 mg per cohort. In Part 2 of the study, D07001-softgel will be administered at the 2 dose levels selected for expansion from Part 1 of the study.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531320
Sponsor's protocol ID
Inno-GO-03
Status last verified
Nov 2023
First submitted
10 Apr 2018
Last updated
24 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing D07001-softgel capsules in people with Gastrointestinal Cancer and Biliary Tract Cancer, run by InnoPharmax Inc. at 4 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 26 inclusion and 20 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Establish the Maximum Tolerated Dose (MTD) (time frame: During Cycle 1 of treatment (each cycle is 21 days) for each subject). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03531320.

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 24 Nov 2023.

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