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Advanced Solid MalignanciesPhase 1NCT01800630

Phase1 Study of Gemcitabine HCl Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

A Phase 1 study testing Gemcitabine HCl Oral Formulation in people with Advanced Solid Malignancies and Malignant Lymphomas, run by InnoPharmax Inc. at 3 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

Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation (D07001-F4). Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Gemcitabine HCl Oral Formulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
3 sitesTaiwan
Study dates
Apr 2013to Mar 2016
Phase
Phase 1
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged 20 years and older
  • Signed and dated informed consent form
  • Patients with advanced solid malignancies and malignant lymphomas with histological or pathologic confirmation who have failed standard therapies or for which no standard therapy exists
  • Both measurable and non-measurable disease allowed (measurable disease per RECIST, version 1.1, or Revised Response Criteria for Malignant Lymphoma [Cheson criteria])
  • World Health Organization (WHO) performance status 0 to 2
  • At least 28 days have elapsed (before screening) since the patient's prior systemic therapy, radiotherapy, or any major surgery (excluding diagnostic biopsy or venous access device placement)
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  • Patient has
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm³
  • Platelet count ≥ 75,000 cells/mm³
  • Hemoglobin ≥ 9 g/dL.
  • Patient has adequate liver function, demonstrated by:
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5*the upper limit of normal (ULN) (≤ 5.0*ULN in case of liver metastasis)
  • Total bilirubin ≤ 1.5 mg/dL (unless due to Gilbert's syndrome)
  • Albumin ≥ 2.5 g/dL
  • International normalized ratio (INR) < 1.5
  • Patient has adequate renal function:
  • Serum creatinine ≤ 1.5*ULN.
  • Patient has a life expectancy > 12 weeks.
  • If a woman of child-bearing potential, patient has a negative pregnancy test and is not breast feeding.
  • If a woman of child-bearing potential, patient is using a medically acceptable form as two barrier methods (e.g., combination of condom, diaphragm, intrauterine device), hormonal contraception (estrogen or progesterone agents) or one 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 will also adhere to similar birth control methods
  • Patient is willing to comply with protocol-required visit schedule and visit requirements

Who cannot join

  • Patient is receiving full-dose (therapeutic) anticoagulation therapy.
  • Patient is intolerant or allergic or has a known hypersensitivity to gemcitabine
  • Patient has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater).
  • Patient has uncontrolled serious cardiac arrhythmia.
  • Patient has known brain metastases or any leptomeningeal metastases.
  • Patient has any unresolved toxicity (>Grade 1) from previous anticancer therapy with the exception of renal and liver function which are required to be in the range as described in inclusion criteria and peripheral neuropathy acceptable if resolved to at least grade 2.
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  • Patient has received radiotherapy of more than 10 Gy within 6 months of screening.
  • 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 screening
  • Patient received systemic treatment for infection within 14 days of screening.
  • Patient has known human immunodeficiency virus (HIV) infection.
  • Patient has hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical history.
  • Patient has received yellow fever vaccine and other live attenuated vaccines within the last 4 weeks
  • Patient has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in a clinical trial.
  • Patients have gastrointestinal disease/prior surgery that may interfere with adequate oral therapy absorption
  • Patients after allogeneic stem cell transplantation
  • Patients with less than 12 months from autologous stem cell transplantation

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

About this study

Official title: An Open Label, Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and 12 of 4 21-day cycles each to further characterize safety and tolerability.

Being tested
Gemcitabine HCl Oral Formulation
Medical subject headings
Lymphoma

What participants receive

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

  • Gemcitabine HCl Oral FormulationDrug

    Also called D07001-F4

Study groups in NCT01800630
Study groupRoleWhat they receive
Gemcitabine HCl Oral Formulation (D07001-F4)ExperimentalSubjects will receive a single 5-mg (nontherapeutic) dose of gemcitabine (Gemzar®) via an IV push and then treated with Gemcitabine HCl Oral Formulation (D07001-F4)according to assigned cohort (2 mg to 80 mg) on Day 1, 3, 5, 8, 10, and 12 of 4 21-day cycles study treatment period.
Receives: Drug: Gemcitabine HCl Oral Formulation

What is being measured

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

  1. To determine MTD and DLT of Gemcitabine Oral formulation

    MTD will be determined by study structure and DLT will be determined by definition

    Measured: During the 21-day cycle 1 treatment

Secondary outcomes (4)

  1. AE/SAE incidences

    AEs will be assessed via the CTCAE version 4.03

    Measured: Throughout treatment and 30-day follow-up (estimated average of 5 months)

  2. Changes from baseline in clinical laboratory test (hematology, biochemistry, coagulation factors and urinalysis) results, vital sign measurements, physical examination findings, and ECG and 2D echocardiogram/multiple-gated acquisition (MUGA) scan results

    Measured: Throughout treatment and 30-day follow-up (estimated average of 5 months)

  3. characterize the PK of D07001-F4

    Measured: cycle 0 and cycle 1 (Day -7~Day 19)

  4. ORR(Objective Response Rate) and tumor response

    Measured: After cycle 2 and cycle 4 treatments (estimated average of 2 months and 4 months)

Timeline

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

  1. First posted28 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2015
  4. Study completionMar 2016

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
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01800630
Sponsor's protocol ID
HR-12-001
Status last verified
Jul 2019
First submitted
23 Feb 2013
Last updated
8 Jul 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine HCl Oral Formulation in people with Advanced Solid Malignancies and Malignant Lymphomas, run by InnoPharmax Inc. at 3 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 21 inclusion and 19 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 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine MTD and DLT of Gemcitabine Oral formulation (time frame: During the 21-day cycle 1 treatment). 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 NCT01800630.

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 8 Jul 2019.

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