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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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Malignant Tumors

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC

Outcome Time Frame:

Day 1-5

Safety Issue:

No

Principal Investigator

Nashat Y. Gabrail, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gabrail Cancer Center Research

Authority:

United States: Food and Drug Administration

Study ID:

HR-11-001

NCT ID:

NCT01678690

Start Date:

August 2012

Completion Date:

January 2014

Related Keywords:

  • Malignant Tumors
  • Neoplasms

Name

Location

Gabrail Cancer Center ResearchCanton, Ohio  44718
Georgia Regents University- Cancer CenterAugusta, Georgia  30912