Solid TumorPhase 1NCT01463982
Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
A Phase 1 study testing Oratecan and Capecitabine in people with Solid Tumor and Advanced Cancer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor, Advanced Cancer
- What is being tested?
- Oratecan and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Dec 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Read the 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
- Conditions
- Solid Tumor, Advanced Cancer
- Being tested
- Oratecan and Capecitabine
- Keywords
- Advanced solid cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oratecan and CapecitabineDrug
Also called Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine
Oratecan in combination with Capecitabine
- Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5
- HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5
- Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14
| Study group | Role | What they receive |
|---|---|---|
| Oratecan and Capecitabine | Experimental | Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine
* Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5
* HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5
* Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14 Receives: Drug: Oratecan and Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)
Measured: Cycle 1 (21 days)
Secondary outcomes (1)
Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)
by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100.
Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100.
Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100.
Measured: tumor response evaluation can continue to receive the study drug until PD confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jina Jung, PhD, Study director, Hanmi Pharmaceuticals.Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463982
- Sponsor's protocol ID
- HM-OTE-103
- Status last verified
- Apr 2015
- First submitted
- 31 Oct 2011
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01463982
- Acronym / sponsor ID
- HM-OTE-103
- Conditions
- Solid Tumor, Advanced Cancer
- Keywords
- Advanced solid cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Posted 23 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oratecan and Capecitabine | Experimental | Drug: Oratecan and CapecitabineOratecan(HM30181AK + Irinotecan HCl) and Capecitabine * Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5 * HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5 * Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oratecan and CapecitabineAlso: Oratecan(HM30181AK + Irinotecan HCl) and CapecitabineOratecan in combination with Capecitabine * Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5 * HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5 * Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14 | Drug | Oratecan and Capecitabine |
Primary outcome
Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
Time frame: Cycle 1 (21 days)
If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)
1 secondary outcome
Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)
Time frame: tumor response evaluation can continue to receive the study drug until PD confirmation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jina Jung, PhD study director
Hanmi Pharmaceuticals.Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oratecan and Capecitabine in people with Solid Tumor and Advanced Cancer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination (time frame: Cycle 1 (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.