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A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer


Phase 1
19 Years
N/A
Open (Enrolling)
Both
Advanced Solid Malignancies

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Trial Information

A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer


Besides the main objective, there are 4 other objectives as follows:

- To assess the safety of Oratecan in combination with capecitabine

- To evaluate anticancer activity of Oratecan in combination with capecitabine in
patients with advanced solid malignancies

- To characterize the pharmacokinetics of Oratecan and its metabolites following oral
administration of OratecanTM in combination with capecitabine


Inclusion Criteria:



- Histologically or cytologically confirmed advanced solid tumor

- Patients who have experienced progressive disease despite of conventional anticancer
therapy. Patients who cannot expect effective treatment or prolonged survival with
conventional anticancer therapy

- Previous chemotherapy, radiotherapy and surgical operation are allowed if they are
discontinued for at least 4 weeks prior to D0 and all adverse events are resolved

- Aged ≥19

- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to
2

- A life expectancy greater than 12 weeks

- Adequate bone marrow, renal and liver function.

- Subjects must provide written informed consent prior to performance of study specific
procedures or assessments, and must be willing to comply with treatment and follow up
assessments and procedures

Exclusion Criteria:

- Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.

- Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are
candidates for planned HSCT

- Patients who have GI malabsorption or difficulty taking oral medication

- Patients who have psychiatric or congenital disorder Subjects who, in the
investigator's opinion, cannot be treated per protocol due to functional impairments

- Pregnant or breast-feeding patients; Women of childbearing potential without adequate
contraception (Men must use adequate contraception.)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, 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 21 during Cycle 1

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

HM-OTE-103

NCT ID:

NCT01463982

Start Date:

December 2010

Completion Date:

December 2012

Related Keywords:

  • Advanced Solid Malignancies
  • HM-OTE-103
  • Neoplasms

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