Ovarian CancerPhase 2GPMOC202NCT01276548
A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer
A Phase 2 study testing Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC and Genexol® 175mg/m2 plus Carboplatin 5 AUC in people with Ovarian Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC and Genexol® 175mg/m2 plus Carboplatin 5 AUC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Sep 2012
- Phase
- Phase 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who aged 18 years or older
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
Who cannot join
- Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
- Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
- Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center
Seoul, Songpa-gu, Pungnap-2 Dong, 138-736
About this study
The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC, Genexol® 175mg/m2 plus Carboplatin 5 AUC
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genexol®-PM 260mg/m2 plus Carboplatin 5 AUCDrug
Genexol® 175mg/m2 plus Carboplatin 5 AUCDrug
| Study group | Role | What they receive |
|---|---|---|
| Genexol®-PM plus Carboplatin | Experimental | Not described Receives: Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC |
| Genexol® plus Carboplatin | Active comparator | Not described Receives: Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate
Proportion of subjects with CA125 and RECIST composite response rate was evaluated and compared between the groups. CA125 was evaluated among subjects without a measurable disease, while RECIST was evaluated among subjects with a measurable disease; discordance between the response rates by RECIST and CA125 were deemed as nonresponse.
Measured: up to 6 cycles
Secondary outcomes (3)
Overall Survival
The period from the date of first administration to the date of the patient's death
Measured: up to 3 years
Progression Free Survival
The period from the date of first administration to the date of objective tumor progression by CA125 and RECIST or death
Measured: up to 3 years
Time to Progression
The period from the date of first administration to the date of tumor progression by CA125 and RECIST or objective tumor progression, excluding progression-free death
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276548
- Sponsor's protocol ID
- GPMOC202
- Acronym
- GPMOC202
- Status last verified
- May 2017
- First submitted
- 12 Jan 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01276548
- Acronym / sponsor ID
- GPMOC202 / GPMOC202
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Jan 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 purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genexol®-PM plus Carboplatin | Experimental | Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC |
| Genexol® plus Carboplatin | Active comparator | Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who aged 18 years or older
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
Key exclusion criteria (3 listed)
- Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
- Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
- Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit
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®-PM 260mg/m2 plus Carboplatin 5 AUC | Drug | Genexol®-PM plus Carboplatin |
| Genexol® 175mg/m2 plus Carboplatin 5 AUC | Drug | Genexol® plus Carboplatin |
Primary outcome
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate
Time frame: up to 6 cycles
Proportion of subjects with CA125 and RECIST composite response rate was evaluated and compared between the groups. CA125 was evaluated among subjects without a measurable disease, while RECIST was evaluated among subjects with a measurable disease; discordance between the response rates by RECIST and CA125 were deemed as nonresponse.
3 secondary outcomes
Overall Survival
Time frame: up to 3 years
Progression Free Survival
Time frame: up to 3 years
Time to Progression
Time frame: up to 3 years
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 9 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC and Genexol® 175mg/m2 plus Carboplatin 5 AUC in people with Ovarian 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 3 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: finished, as of the sponsor's last update on 9 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 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?
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?
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate (time frame: up to 6 cycles). 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 9 May 2017.