Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies (Oratecan-103)
This study is currently recruiting participants.
Verified October 2011 by Hanmi Pharmaceutical Company Limited
Sponsor:
Hanmi Pharmaceutical Company Limited
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01463982
First received: October 31, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Malignancies |
Drug: Irinotecan, HM30181AK, Capecitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hanmi Pharmaceutical Company Limited:
Primary Outcome Measures:
- MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 21 during Cycle 1 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Irinotecan, HM30181AK, Capecitabine
Oratecan in combination with Capecitabine
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463982
Contacts
| Contact: Kyung Mi Park | kmpark@hanmi.co.kr |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Tae Yoo Kim, MD, PhD | |
| Principal Investigator: Tae Yoo Kim, MD, PhD | |
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
More Information
No publications provided
| Responsible Party: | Hanmi Pharmaceutical Company Limited |
| ClinicalTrials.gov Identifier: | NCT01463982 History of Changes |
| Other Study ID Numbers: | HM-OTE-103 |
| Study First Received: | October 31, 2011 |
| Last Updated: | October 31, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Hanmi Pharmaceutical Company Limited:
|
HM-OTE-103 |
Additional relevant MeSH terms:
|
Neoplasms Irinotecan Capecitabine Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013