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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01491204
First received: December 5, 2011
Last updated: December 11, 2011
Last verified: December 2011

December 5, 2011
December 11, 2011
August 2006
October 2008   (final data collection date for primary outcome measure)
MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01491204 on ClinicalTrials.gov Archive Site
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Not Provided
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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 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

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 malignant solid tumor refractory to standard therapy.

Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started on day 29.

Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of paclitaxel

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: Paclitaxel+HM30181
oral, 3times for 4weeks
Experimental: paclitaxel +HM30181
Intervention: Drug: Paclitaxel+HM30181
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
19 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01491204
HM-OXL-101
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Not Provided
Hanmi Pharmaceutical Company Limited
December 2011

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