Gynecologic CancerPhase 1NCT02739529
Study to Evaluate the Efficacy and Safety of Genexol-PM Once a Week for Gynecologic Cancer
A Phase 1 study testing Genexol-PM in people with Gynecologic Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial. Read more about this study
- Who is it for?
- Ages 20 to 79 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Genexol-PM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Mar 2018
- 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 20 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who aged 20 years or older and under 80 year old female
- Patients who were diagnosed histologically or cytologically or who were scheduled to reccur as an gynecologic cancer (epithelial ovarian cancer , fallopian tube cancer, primary peritoneal cancer, cervical cancer, uterine corpus cance, etc)
- Patients seemed appropriate for Paclitaxel and Carboplatin combination therapy for the treatment
- Patients whose ECOG performance score are 0-2
- Patients who have adequate blood, kidney and liver function on screening within 14 days before the administration of the test drugs
- Hb ≥ 10g/dl: Patients with less than 10g/dl of hemoglobin level were not allowed to use the test drugs unless they were recovered to 10g/dl or more.
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- ANC ≥ 1500/mm3
- Platelet Count ≥ 100,000/mm3
- Serum AST and ALT ≤ 2.5 X ULN
- Serum ALP ≤ 2.5 X ULN
- Serum creatinine ≤ 2.5 X ULN
- Patients who participated voluntarily and who provided written informed consent before participating in the study
Who cannot join
- Patients with the history of carcinoma in the past 5 years other than gynecologic cancer
- Patients who received radiotherapy at abdominal cavity or pelvis
- Patients who were receiving immunotherapy or hormone therapy
- Patients who received a major surgery other than debulking surgery within 2 weeks before the screening
- Patients with a past or present medical history of metastasis in central nervous system (CNS)
- Patients with NCI CTCAE V4.0 Grade 1 or more sensory or motor neuropathy
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- Patients with severe comorbidities as follows
- medical or mental condition impossible to understand the clinical trial and provide a written informed consent, based on the investigators' decision
- severe cardiovascular disease (such as ischemic heart disease requiring medical therapy, myocardial infarction within the last 6 months, and grade 2~4 congestive heart failure defined by New York Heart Association criteria)
- uncontrolled active infectious disease
- hypersensitivity to the test drugs or the vehicle
- Patients who participated in another study within 4 weeks before the screening
- Pregnant, lactating women or Patients who do not use contraceptive methods that can be medically accepted to the possibility of pregnancy in female volunteers
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samyang Biopharmaceuticals
Seoul
Miryung Jin, +82-2-740-7289, miryung.jin@samyang.com
Yong man Kim
About this study
Official title: Dose-dense Paclitaxel (Genexol®-PM) Once a Week in Combination With Carboplatin Every 3 Weeks for Gynecologic Cancer (Adult Solid Tumor): a Phase I Trial
Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.
- Conditions
- Gynecologic Cancer
- Being tested
- Genexol-PM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genexol-PMDrug
Cremophor EL-free polymeric micelle of paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Genexol-PM 100mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1 Receives: Drug: Genexol-PM |
| Cohort 2 | Experimental | Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1 Receives: Drug: Genexol-PM |
| Cohort 3 | Experimental | Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 6 AUC IV infusion D1 Receives: Drug: Genexol-PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD)
MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT
Measured: 2 years
The recommended dose for the phase II study
Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups
Measured: 2 years
Secondary outcomes (2)
The dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) was defined as one of the following cases. NCI CTCAE V3.0 Grade 3 or more hypersensitivity despite premedication, Non-Hematological Toxicity other than nausea and vomiting, Hematological toxicity.
Measured: 2 years
Toxicities
Clinical/laboratory toxicities were monitored after the treatment, in order to evaluate safety and tolerance of the test drugs, and adverse events, which were maintained until visit on discontinuation date, were followed until recovered or stabilized
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Man Kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739529
- Sponsor's protocol ID
- GPMOC101
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dense Paclitaxel (Genexol®-PM) Once a Week in Combination With Carboplatin Every 3 Weeks for Gynecologic Cancer (Adult Solid Tumor): a Phase I Trial
- ClinicalTrials.gov ID
- NCT02739529
- Acronym / sponsor ID
- GPMOC101
- Conditions
- Gynecologic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 15 Apr 2016 (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.
Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Genexol-PMGenexol-PM 100mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1 |
| Cohort 2 | Experimental | Drug: Genexol-PMGenexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1 |
| Cohort 3 | Experimental | Drug: Genexol-PMGenexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 6 AUC IV infusion D1 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who aged 20 years or older and under 80 year old female
- Patients who were diagnosed histologically or cytologically or who were scheduled to reccur as an gynecologic cancer (epithelial ovarian cancer , fallopian tube cancer, primary peritoneal cancer, cervical cancer, uterine corpus cance, etc)
- Patients seemed appropriate for Paclitaxel and Carboplatin combination therapy for the treatment
- Patients whose ECOG performance score are 0-2
- Patients who have adequate blood, kidney and liver function on screening within 14 days before the administration of the test drugs
Key exclusion criteria (13 listed)
- Patients with the history of carcinoma in the past 5 years other than gynecologic cancer
- Patients who received radiotherapy at abdominal cavity or pelvis
- Patients who were receiving immunotherapy or hormone therapy
- Patients who received a major surgery other than debulking surgery within 2 weeks before the screening
- Patients with a past or present medical history of metastasis in central nervous system (CNS)
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 |
|---|---|---|
| Genexol-PMCremophor EL-free polymeric micelle of paclitaxel | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
The maximum tolerated dose (MTD)
Time frame: 2 years
MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT
The recommended dose for the phase II study
Time frame: 2 years
Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups
2 secondary outcomes
The dose limiting toxicity (DLT)
Time frame: 2 years
Toxicities
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Individual participant dataSharing planned: No
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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.
Yong Man Kim 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 Genexol-PM in people with Gynecologic Cancer, run by Samyang Biopharmaceuticals Corporation 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 12 inclusion and 13 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 1 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose (MTD) (time frame: 2 years). 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?
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 1 May 2017.