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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01491204
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : December 13, 2011
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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 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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Paclitaxel+HM30181 Phase 1

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 and its metabolites following oral administration of Oraxol.

To evaluate anticancer activity of Oraxol.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: paclitaxel +HM30181 Drug: Paclitaxel+HM30181
oral, 3times for 4weeks

Primary Outcome Measures :
  1. MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ]

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01491204     History of Changes
Other Study ID Numbers: HM-OXL-101
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action