Clinical trial NCT01463982: Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Advanced Cancer
Keywords: Advanced solid cancer
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2011-11-02
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine

Detailed description: 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

Eligibility criteria: 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.)

Primary outcomes:
measure: Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
timeFrame: Cycle 1 (21 days)
Secondary outcomes:
measure: Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)
timeFrame: tumor response evaluation can continue to receive the study drug until PD confirmation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Pharmaceuticals, Co., Ltd
Study officials:
affiliation: Hanmi Pharmaceuticals.Co.,Ltd
name: Jina Jung, PhD
role: STUDY_DIRECTOR
References: