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Advanced Solid MalignanciesPhase 1NCT00986843

Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSouth Korea
Study dates
Jun 2008to Sep 2012
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.
  • 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
  • Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
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  • 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.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

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)X2 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.

The irinotecan hydrochloric acid (HCl) tablet is escalated and administered per body surface area (BSA). The dose of HM30181A 60 mg is fixed.

The Route of administration of irinitecan and HM30181A is oral. Each cycle consists of 21 days. Drugs are administered daily for 10 consecutive days (D1, 2, 3, 4, 5, 8, 9, 10, 11 and 12) followed by a washout of 9 days.

Read the detailed description

Besides the main objective, there are 3 other objectives as follows.

  1. To determine dose-limiting toxicity (DLT) of OratecanTM
  2. To characterize the pharmacokinetics of HM30181A, irinotecan and its metabolites (SN-38 and SN-38G) following oral administration of OratecanTM
  3. 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.

Being tested
HM30181AK tablet + Irinotecan tablets
Keywords
HM30181A, Irinotecan, 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

Study groups in NCT00986843
Study groupRoleWhat they receive
HM30181AK tablet + Irinotecan tabletsExperimentalHM30181AK tablet + Irinotecan tablets
Receives: Drug: HM30181AK tablet + Irinotecan tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted30 Sep 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionFeb 2010
  4. Study completionSep 2012

Resources

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00986843
Sponsor's protocol ID
HM-OTE-102
Status last verified
Apr 2013
First submitted
29 Sep 2009
Last updated
5 Apr 2013
Results posted
No
Data monitoring committee
No

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 9 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 5 Apr 2013. 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?

On the ClinicalTrials.gov record for NCT00986843.

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 5 Apr 2013.

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