Advanced Solid MalignanciesPhase 1Oratecan-101NCT00979563
Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies
A Phase 1 study testing HM30181AK tablet + Irinotecan tablets in people with Advanced Solid Malignancies, 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 OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy or for which no established therapy exists at the time of study participation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- HM30181AK tablet + Irinotecan tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 tumors
- 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 (excluding irinotecan), radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved (6 weeks for nitrosoureas and mitomycin)
- Aged ≥18
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
- A life expectancy greater than 12 weeks
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- Adequate bone marrow (platelet≥100 x 109/L, hemoglobin≥10.0g/dl and ANC≥ 1.5 x 109/L, renal (Creatinine≤1.5mg/dl) and liver function (AST/ALT/ALP ≤ 3 x upper limit of normal and total bilirubin≤2mg/dl) and no abnormal heart and lung function However, AST/ALT/ALP ≤ 5 x upper limit of normal for patients with liver metastases and ALP level ≤ 5 x upper limit of normal for patients with bone metastases are allowed.
- Patients with no need of radiotherapy (except for true oncologic emergency occurring after entry on study [e.g. acute spinal cord compression], other anticancer drugs and immunotherapy during the trial
- 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 ( including leukemia, lymphoma, multiple myeloma, myelodysplastic syndromes, myeloproliferative disorders), ileus, CNS metastasis, and with active infections requiring parenteral or systemic antibacterial, antiviral, or antifungal therapy. Patients with infections may participate in this clinical trial after complete recovery or control of the infection.
- Patients with chronic malabsorption, or who have undergone total colectomy.
- Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
- History of congestive heart failure, atrial arrhythmia or ventricular arrhythmia requiring medication; Patients who had treatment for myocardial infarction or any other acute coronary syndrome event within the past 6 months.
- History of significant psychological or neurological disorders that would affect providing informed consent or interfere with compliance with demands of and participation in the clinical trial.
- Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments due to any other severe co-morbid medical conditions.
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- Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
- Subjects who have no intention of following the requirements of the protocol or the follow-up management. Subjects who cannot be followed up regularly due to psychological, social, family, logistic, and geographical reasons.
- Subjects who have been treated with PGP inhibitors (cyclosporine A and verapamil), which are contraindicated medications, will have a wash-out period of 2 weeks.
- Subjects who were administered with other investigational products within 28 days before screening.
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 and Pharmacokinetic Profile of OratecanTM in Patients With Advanced Solid Cancer(Q1DX5/W for 3W)
The main objective of this study is to determine the maximum tolerated dose (MTD) of OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy or for which no established therapy exists at the time of study participation.
Read the detailed description
Besides the main objective, there are 3 other objectives as follows.
- To determine dose-limiting toxicity (DLT) of OratecanTM
- To characterize the pharmacokinetics of HM30181A, irinotecan and its metabolites (SN-38 and SN-38G) following oral administration of OratecanTM
- To evaluate anticancer activity of OratecanTM in patients with advanced solid malignancies Groups of 3 patients per cohort or dose level will be treated with escalating doses of irinotecan in combination with a fixed 60mg dose of HM30181A.
If 0/3 patients at any dose level experience a DLT, the dose of irinotecan will be escalated by 10 mg/m2 in the next dose level. If 1/3 patients at any dose level experience a DLT, the cohort will be expanded by 3 additional patients to 6 patients. If no additional patients develop DLT, the dose of irinotecan will again be escalated in the next cohort of 3 patients. If 2/3 or 2/6 patients develop DLT, then dose escalation will cease, and the previous dose will be declared the MTD.
- Conditions
- Advanced Solid Malignancies
- Being tested
- HM30181AK tablet + Irinotecan tablets
- Keywords
- HM30181AK, Irinotecan tablet, MTD, DLT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM30181AK tablet + Irinotecan tabletsDrug
HM30181AK 60 mg tablet + Irinotecan 20mg, 5 mg or 2mg tablets
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity evaluation (safety evaluation): Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).
Measured: Toxicity will be evaluated on Day 21 during Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon-ku Kang, MD, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979563
- Sponsor's protocol ID
- HM-OTE-101
- Acronym
- Oratecan-101
- Status last verified
- Sep 2009
- First submitted
- 16 Sep 2009
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. 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 and Pharmacokinetic Profile of OratecanTM in Patients With Advanced Solid Cancer(Q1DX5/W for 3W)
- ClinicalTrials.gov ID
- NCT00979563
- Acronym / sponsor ID
- Oratecan-101 / HM-OTE-101
- Conditions
- Advanced Solid Malignancies
- Keywords
- HM30181AK, Irinotecan tablet, MTD, DLT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
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 OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy or for which no established therapy exists at the time of study participation.
Detailed description
Besides the main objective, there are 3 other objectives as follows.
- To determine dose-limiting toxicity (DLT) of OratecanTM
- To characterize the pharmacokinetics of HM30181A, irinotecan and its metabolites (SN-38 and SN-38G) following oral administration of OratecanTM
- To evaluate anticancer activity of OratecanTM in patients with advanced solid malignancies Groups of 3 patients per cohort or dose level will be treated with escalating doses of irinotecan in combination with a fixed 60mg dose of HM30181A.
If 0/3 patients at any dose level experience a DLT, the dose of irinotecan will be escalated by 10 mg/m2 in the next dose level. If 1/3 patients at any dose level experience a DLT, the cohort will be expanded by 3 additional patients to 6 patients. If no additional patients develop DLT, the dose of irinotecan will again be escalated in the next cohort of 3 patients. If 2/3 or 2/6 patients develop DLT, then dose escalation will cease, and the previous dose will be declared the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed advanced solid tumors
- 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 (excluding irinotecan), radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved (6 weeks for nitrosoureas and mitomycin)
- Aged ≥18
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
Key exclusion criteria (10 listed)
- Patients with hematopoietic malignancies ( including leukemia, lymphoma, multiple myeloma, myelodysplastic syndromes, myeloproliferative disorders), ileus, CNS metastasis, and with active infections requiring parenteral or systemic antibacterial, antiviral, or antifungal therapy. Patients with infections may participate in this clinical trial after complete recovery or control of the infection.
- Patients with chronic malabsorption, or who have undergone total colectomy.
- Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
- History of congestive heart failure, atrial arrhythmia or ventricular arrhythmia requiring medication; Patients who had treatment for myocardial infarction or any other acute coronary syndrome event within the past 6 months.
- History of significant psychological or neurological disorders that would affect providing informed consent or interfere with compliance with demands of and participation in the clinical trial.
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 |
|---|---|---|
| HM30181AK tablet + Irinotecan tabletsHM30181AK 60 mg tablet + Irinotecan 20mg, 5 mg or 2mg tablets | Drug | – |
Primary outcome
Toxicity evaluation (safety evaluation): Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).
Time frame: Toxicity will be evaluated on Day 21 during Cycle 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
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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.
Yoon-ku Kang, MD, Ph.D principal investigator
Asan Medical Center
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 HM30181AK tablet + Irinotecan tablets in people with Advanced Solid Malignancies, 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 9 inclusion and 10 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 7 Dec 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity evaluation (safety evaluation): Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0). (time frame: Toxicity will be evaluated on Day 21 during Cycle 1). 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 7 Dec 2011.