Malignant TumorsEarly Phase 1NCT01678690
An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
A Early Phase 1 study testing Gemcitabine HCl Oral Formulation in people with Malignant Tumors, run by InnoPharmax Inc. at 4 sites in 2 countries.
Trial summary
Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort), to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4) administered once on Day 1 with 7 Days of study follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- Gemcitabine HCl Oral Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2012to Apr 2014
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years and older.
- Signed and dated informed consent form.
- Subjects with malignancies with histological or pathologic confirmation and who are clinically stable.
- History of treatment with at least 1 cytotoxic chemotherapy regimen for the current malignancy.
- If the subject has received cytotoxic chemotherapy within the past 14 days, the subject is beyond the nadir of white blood cell and platelet counts.
- At least 28 days have elapsed since the subject's prior radiotherapy or any major surgery (excluding diagnostic biopsy or venous access device placement).
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- World Health Organization (WHO) performance status 0 to 2
- Subject has an ANC ≥1500 cells/mm³, platelet count ≥ 100,000 cells/mm³, and hemoglobin ≥ 9 g/dL.
- Subject has adequate liver function demonstrated by transaminases within normal limits (aspartate transaminase and alanine transaminase), total bilirubin ≤ 1.5 mg/dL (unless due to Gilbert's syndrome), albumin ≥ 2.5 g/dL, international normalized ratio [INR] < 1.5).
- Subject has adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal.
- Subject has a life expectancy >24 weeks.
- If a women of child-bearing potential, subject has a negative pregnancy test and is not breast-feeding.
- If a women of child-bearing potential, subject is using a medically acceptable form of birth control prior to screening and for the duration of their study participation and for 1 month after the end of the study.
- Subject is willing to comply with protocol-required visit schedule and visit requirements and provide written informed consent.
Who cannot join
- Subject has rapidly progressive disease or rapid clinical deterioration as assessed by the Investigator.
- Subject is receiving full-dose (therapeutic) anticoagulation therapy.
- Subject is receiving concomitant radiotherapy.
- Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine.
- Subject has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater).
- Subject has uncontrolled serious cardiac arrhythmia.
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- Subject has known active brain metastases, or any leptomeningeal metastases.
- Subject has a history of drug or alcohol abuse within last year.
- Subject has documented cerebrovascular disease.
- Subject has a seizure disorder not controlled on medication.
- Subject received an investigational agent within 30 days of screening.
- Subject received systemic treatment for infection within 14 days of screening.
- Subject has known human immunodeficiency virus infection or viral hepatitis.
- Subject has any other serious medical condition that, in the investigator's medical opinion, would preclude safe participation in a clinical trial.
- Subject has gastrointestinal disease or prior gastrointestinal surgery that may interfere with adequate oral therapy absorption.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Georgia Regents University- Cancer Center
Augusta, Georgia, 30912
Gabrail Cancer Center Research
Canton, Ohio, 44718
Gabrail Cancer Center Research
Dover, Ohio, 44622
About this study
Official title: An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort), to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4) administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and safety will also be assessed during this 1-week period.
- Conditions
- Malignant Tumors
- Being tested
- Gemcitabine HCl Oral Formulation
- Medical subject headings
- Neoplasms
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
Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine HCl Oral Formulation | Experimental | Subjects will be treated with Gemcitabine HCl Oral Formulation according to assigned cohort (2 mg or 5 mg or 10 mg) on Day 1 of the 7-day 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.
gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC
Measured: Day 1-5
Secondary outcomes (1)
the proportion of subjects experiencing adverse events all grades, change from baseline in clinical laboratory test results, vital sign measurements, and physical examination findings
Measured: Day 1-8 (+/- 1) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies 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
- Early Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoPharmax Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nashat Y. Gabrail, MD, Principal investigator, Gabrail Cancer Center ResearchSharad Ghamande, MD, Principal investigator, Augusta UniversityChia-Chi Lin, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678690
- Sponsor's protocol ID
- HR-11-001
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2012
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
- ClinicalTrials.gov ID
- NCT01678690
- Acronym / sponsor ID
- HR-11-001
- Conditions
- Malignant Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- InnoPharmax Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Sep 2012 (estimated)
- 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.
Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort), to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4) administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and safety will also be assessed during this 1-week period.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine HCl Oral Formulation | Experimental | Drug: Gemcitabine HCl Oral FormulationSubjects will be treated with Gemcitabine HCl Oral Formulation according to assigned cohort (2 mg or 5 mg or 10 mg) on Day 1 of the 7-day study treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subjects aged 18 years and older.
- Signed and dated informed consent form.
- Subjects with malignancies with histological or pathologic confirmation and who are clinically stable.
- History of treatment with at least 1 cytotoxic chemotherapy regimen for the current malignancy.
- If the subject has received cytotoxic chemotherapy within the past 14 days, the subject is beyond the nadir of white blood cell and platelet counts.
Key exclusion criteria (15 listed)
- Subject has rapidly progressive disease or rapid clinical deterioration as assessed by the Investigator.
- Subject is receiving full-dose (therapeutic) anticoagulation therapy.
- Subject is receiving concomitant radiotherapy.
- Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine.
- Subject has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater).
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 |
|---|---|---|
| Gemcitabine HCl Oral FormulationAlso: D07001-F4Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period | Drug | Gemcitabine HCl Oral Formulation |
Primary outcome
gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC
Time frame: Day 1-5
1 secondary outcome
the proportion of subjects experiencing adverse events all grades, change from baseline in clinical laboratory test results, vital sign measurements, and physical examination findings
Time frame: Day 1-8 (+/- 1) days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
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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.
Nashat Y. Gabrail, MD principal investigator
Gabrail Cancer Center Research
Sharad Ghamande, MD principal investigator
Augusta University
Chia-Chi Lin, MD principal investigator
National Taiwan University Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gemcitabine HCl Oral Formulation in people with Malignant Tumors, run by InnoPharmax Inc. at 4 sites in 2 countries.
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 14 inclusion and 15 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 2 Sep 2016. 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 United States, 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC (time frame: Day 1-5). 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 2 Sep 2016.