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Phase I 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


Phase 1
19 Years
70 Years
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

Phase I 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


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 and its metabolites following oral administration of
Oraxol.

To evaluate anticancer activity of Oraxol.


Inclusion Criteria:



1. Patients must histologically or cytologically be diagnosed to have an advanced solid
cancer.

2. 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

3. 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.

4. ECOG performance status ≤ 2

5. Life expectancy ≥ 12 weeks

6. 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 Criteria:

1. 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)

2. Patients who have received bone marrow transplant or are to receive bone marrow
transplant.

3. 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.

4. Pregnant or lactating or with childbearing potential without use of adequate
contraception (in case of men, appropriate contraception is required).

5. Patients who are on PGP inhibitor such as Cyclosporine or Verapamil which are
prohibited.: Such patients may qualify after two-week wash-out period.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD determination

Outcome Time Frame:

Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

HM-OXL-101

NCT ID:

NCT01491204

Start Date:

August 2006

Completion Date:

October 2008

Related Keywords:

  • Advanced Solid Tumors

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