Status:
COMPLETED
Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of Oral Paclitaxel in Patients With Advanced Solid Cancer
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
19-70 years
Phase:
PHASE1
Brief Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral Paclitaxel. Eligible subjects of this study are patients with histologically or cytologically confirmed malign...
Detailed Description
Besides the main objective, there are 3 other objectives as follows. To determine dose-limiting toxicity (DLT) Of Oraxol. To characterize the pharmacokinetics of HM30181A(pgp inhibitor), paclitaxel a...
Eligibility Criteria
Inclusion
- Patients must histologically or cytologically be diagnosed to have an advanced solid cancer.
- Patients have progressive disease in spite of standard anti-cancer therapy or are not expected to benefit or prolong survival from any existing anti-cancer therapy
- Patients who received chemotherapy, radiation therapy, surgery must have passed at least 4weeks since the final treatment and must have fully recovered from the toxicities Patients treated by Nitrosoureas or Mitomycin C must wait 6 weeks before becoming eligible.
- ECOG performance status ≤ 2
- Life expectancy ≥ 12 weeks
- Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL \*AST/ALT/ALP ≤ 3 X the upper limit of normal but \<5 if liver or bone metastasis is present
Exclusion
- Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
- Patients who have received bone marrow transplant or are to receive bone marrow transplant.
- Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
- Pregnant or lactating or with childbearing potential without use of adequate contraception (in case of men, appropriate contraception is required).
- Patients who are on PGP inhibitor such as Cyclosporine or Verapamil which are prohibited.: Such patients may qualify after two-week wash-out period.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01491204
Start Date
August 1 2006
End Date
October 1 2008
Last Update
December 13 2011
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