Trial record 1 of 1 for:    HR-11-001
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An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors

This study is currently recruiting participants.
Verified January 2014 by InnoPharmax Inc.
Sponsor:
Information provided by (Responsible Party):
InnoPharmax Inc.
ClinicalTrials.gov Identifier:
NCT01678690
First received: August 29, 2012
Last updated: January 16, 2014
Last verified: January 2014

August 29, 2012
January 16, 2014
August 2012
June 2014   (final data collection date for primary outcome measure)
gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC [ Time Frame: Day 1-5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01678690 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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 1-15 (+/- 3) days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
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.

Not Provided
Interventional
Phase 0
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Malignant Tumors
Drug: Gemcitabine HCl Oral Formulation
Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period
Other Name: D07001-F4
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
Intervention: Drug: Gemcitabine HCl Oral Formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female subjects aged 18 years and older.
  2. Signed and dated informed consent form.
  3. Subjects with malignancies with histological or pathologic confirmation and who are clinically stable.
  4. History of treatment with at least 1 cytotoxic chemotherapy regimen for the current malignancy.
  5. 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.
  6. At least 28 days have elapsed since the subject's prior radiotherapy or any major surgery (excluding diagnostic biopsy or venous access device placement).
  7. World Health Organization (WHO) performance status 0 to 2
  8. Subject has an ANC ≥1500 cells/mm³, platelet count ≥ 100,000 cells/mm³, and hemoglobin ≥ 9 g/dL.
  9. 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).
  10. Subject has adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal.
  11. Subject has a life expectancy >24 weeks.
  12. If a women of child-bearing potential, subject has a negative pregnancy test and is not breast-feeding.
  13. 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.
  14. Subject is willing to comply with protocol-required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria:

  1. Subject has rapidly progressive disease or rapid clinical deterioration as assessed by the Investigator.
  2. Subject is receiving full-dose (therapeutic) anticoagulation therapy.
  3. Subject is receiving concomitant radiotherapy.
  4. Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine.
  5. Subject has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater).
  6. Subject has uncontrolled serious cardiac arrhythmia.
  7. Subject has known active brain metastases, or any leptomeningeal metastases.
  8. Subject has a history of drug or alcohol abuse within last year.
  9. Subject has documented cerebrovascular disease.
  10. Subject has a seizure disorder not controlled on medication.
  11. Subject received an investigational agent within 30 days of screening.
  12. Subject received systemic treatment for infection within 14 days of screening.
  13. Subject has known human immunodeficiency virus infection or viral hepatitis.
  14. Subject has any other serious medical condition that, in the investigator's medical opinion, would preclude safe participation in a clinical trial.
  15. Subject has gastrointestinal disease or prior gastrointestinal surgery that may interfere with adequate oral therapy absorption.
Both
18 Years and older
No
Contact: Kelly Lin +886-2-8797-7607 ext 600 kelly.lin@innopharmax.com
United States,   Taiwan
 
NCT01678690
HR-11-001
No
InnoPharmax Inc.
InnoPharmax Inc.
Not Provided
Principal Investigator: Nashat Y. Gabrail, MD Gabrail Cancer Center Research
Principal Investigator: Sharad Ghamande, MD Georgia Regents University
Principal Investigator: Chia-Chi Lin, MD National Taiwan University Hospital
InnoPharmax Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP