- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01678690
An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
August 31, 2016 updated by: InnoPharmax Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 10048
- National Taiwan University Hospital
-
-
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Georgia Regents University- Cancer Center
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Gabrail Cancer Center Research
-
Dover, Ohio, United States, 44622
- Gabrail Cancer Center Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemcitabine HCl Oral Formulation
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
|
Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC
Time Frame: Day 1-5
|
Day 1-5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Day 1-8 (+/- 1) days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nashat Y. Gabrail, MD, Gabrail Cancer Center Research
- Principal Investigator: Sharad Ghamande, MD, Augusta University
- Principal Investigator: Chia-Chi Lin, MD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
August 29, 2012
First Submitted That Met QC Criteria
August 30, 2012
First Posted (Estimate)
September 5, 2012
Study Record Updates
Last Update Posted (Estimate)
September 2, 2016
Last Update Submitted That Met QC Criteria
August 31, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-11-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Tumors
-
Gustave Roussy, Cancer Campus, Grand ParisCompletedMalignant Tumors | Refractory TumorsFrance
-
Peking Union Medical College HospitalPeking University; Peking University Cancer Hospital & InstituteRecruiting
-
Bristol-Myers SquibbOno Pharmaceutical Co. LtdCompletedMalignant TumorsJapan
-
Nanjing Leads Biolabs Co.,LtdRecruiting
-
Memorial Sloan Kettering Cancer CenterRecruitingMalignant Solid TumorsUnited States
-
LaNova Medicines LimitedSuspendedMalignant TumorsChina
-
SUNHO(China)BioPharmaceutical CO., Ltd.RecruitingAdvanced Malignant TumorsChina
-
Fudan UniversityRecruitingAdvanced Malignant TumorsChina
-
AkesoRecruitingAdvanced Malignant TumorsChina
Clinical Trials on Gemcitabine HCl Oral Formulation
-
InnoPharmax Inc.CompletedAdvanced Solid Malignancies | Malignant LymphomasTaiwan
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCCompleted
-
Lyndra Inc.TerminatedHealthy | Gastric RetentionUnited Kingdom
-
Cylene PharmaceuticalsUnknownBreast Cancer | Multiple Myeloma | Advanced Solid Tumors | Inflammatory Breast Cancer | Castleman's DiseaseUnited States
-
Helsinn Healthcare SACompletedNon Small Cell Lung Cancer | Cachexia; CancerUnited States, Croatia, Australia, Belgium, Russian Federation, Poland, Romania, Ukraine
-
Glo Science, Inc.EEC Institute, Inc.CompletedPeriodontal Diseases | Tooth DiscolorationUnited States
-
AstraZenecaQuotient SciencesCompleted
-
ViiV HealthcareGlaxoSmithKlineNot yet recruiting