Advanced Metastatic Gastric CancerPhase 1/2NCT01491217
A Study of Oraxol® in Gastric Cancer Patients
A Phase 1/2 study testing Paclitaxel in people with Advanced Metastatic Gastric Cancer and Recurrent Gastric Cancer, run by Hanmi Pharmaceutical Company Limited at 2 sites in South Korea.
Trial summary
The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Metastatic Gastric Cancer, Recurrent Gastric Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Pill or oral medicine
- How many people
- 53 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2009to Dec 2012
- Phase
- Phase 1/2
- 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
- Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI)
- Advanced/metastatic/recurred gastric cancer(PhaseII)
- ECOG performance status ≤ 2
- Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL *AST/ALT/ALP ≤ 3 X the upper limit of normal but <5 if liver or bone metastasis is present
Who cannot join
- Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
- Patients who have received bone marrow transplant or are to receive bone marrow transplant.
- Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
Trial locations and contacts
2 sites in 1 country.
Kyung-Mi Park, Ph.D contact
South Korea2 sites, 2 recruiting
- Recruiting
National Cancer Center
Goyang
Sook Ryun Park, M.D, Ph.D
- Recruiting
Seoul National University Hospital
Seoul
Yung-Jue Bang, M.D, Ph.D
About this study
Official title: A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer
The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.
Read the detailed description
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).
- Being tested
- Paclitaxel
- Keywords
- Oraxol®, oral paclitaxel, paclitaxel, HM30181A, MTD, DLT, RD
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
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: DLT will be assessed on 28days of 1 cycle
Overall response rate(ORR) evaluation
It is measured up to confirmation of tumor response(CR, PR)
Tumor response will be evaluated by RECIST v1.0.
Measured: Response will be evaluated every Cycle 2(8weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startMay 2009
- Primary completionMar 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Metastatic Gastric CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yung-Jue Bang, MD. Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491217
- Sponsor's protocol ID
- HM-OXL-201
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee KW, Lee KH, Zang DY, Park YI, Shin DB, Kim JW, Im SA, Koh SA, Yu KS, Cho JY, Jung JA, Bang YJ. Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer. Oncologist. 2015 Aug;20(8):896-7. doi: 10.1634/theoncologist.2015-0202. Epub 2015 Jun 25.
PubMed 26112004
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT01491217
- Acronym / sponsor ID
- HM-OXL-201
- Keywords
- Oraxol®, oral paclitaxel, paclitaxel, HM30181A, MTD, DLT, RD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Dec 2011 (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 objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.
Detailed description
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (4 listed)
- Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI)
- Advanced/metastatic/recurred gastric cancer(PhaseII)
- ECOG performance status ≤ 2
- Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL *AST/ALT/ALP ≤ 3 X the upper limit of normal but <5 if liver or bone metastasis is present
Key exclusion criteria (3 listed)
- Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
- Patients who have received bone marrow transplant or are to receive bone marrow transplant.
- Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
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 |
|---|---|---|
| PaclitaxelHM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules | Drug | – |
Primary outcome
Toxicity evaluation (safety evaluation)
Time frame: DLT will be assessed on 28days of 1 cycle
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).
Overall response rate(ORR) evaluation
Time frame: Response will be evaluated every Cycle 2(8weeks)
It is measured up to confirmation of tumor response(CR, PR) Tumor response will be evaluated by RECIST v1.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 26112004Lee KW, Lee KH, Zang DY, Park YI, Shin DB, Kim JW, Im SA, Koh SA, Yu KS, Cho JY, Jung JA, Bang YJ. Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer. Oncologist. 2015 Aug;20(8):896-7. doi: 10.1634/theoncologist.2015-0202. Epub 2015 Jun 25.
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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.
Kyung-Mi Park, Ph.D contact
Yung-Jue Bang, MD. Ph.D principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paclitaxel in people with Advanced Metastatic Gastric Cancer and Recurrent Gastric Cancer, run by Hanmi Pharmaceutical Company Limited at 2 sites 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 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 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Mi Park, Ph.D (kmpark@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity evaluation (safety evaluation) (time frame: DLT will be assessed on 28days of 1 cycle). The study lists 2 primary outcomes in all. 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 NCT01491217, which also lists 1 linked publication.
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 13 Dec 2011.