Ovarian CancerPhase 1NCT00877253

Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

A Phase 1 study testing Genexol-PM 220mg/㎡, Carboplatin 5AUC, Genexol-PM 260mg/㎡, Carboplatin 5AUC and Genexol-PM 300mg/㎡, Carboplatin 5AUC in people with Ovarian Cancer, run by Samyang Biopharmaceuticals Corporation.

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 purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced 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 220mg/㎡, Carboplatin 5AUC, Genexol-PM 260mg/㎡, Carboplatin 5AUC and Genexol-PM 300mg/㎡, Carboplatin 5AUC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: No sites listed yet
Study dates: May 2008to Jun 2009
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women ≥ 18 years old.
Signed informed consent before inclusion.
Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
Subjects who have measurable disease by RECIST after debulking surgery.
ECOG performance status of 0, 1, or 2.
Estimated life expectancy of more than 6 months

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Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit
Hb ≥ 10g/dl
ANC ≥ 1.5×10^9/L
Platelet Count ≥ 100×10^9/L
Serum total bilirubin ≤ 1.5×ULN
Serum AST and ALT ≤ 2.5×ULN
Serum ALP ≤ 2.5×ULN
Serum creatinine ≤ 1.5×ULN

Who cannot join

Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
Subjects who have a history of radiotherapy to pelvis or abdominal cavity
Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
Subjects who have other malignancies within the past 5 years
Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit
Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)

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Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0
Subjects who have serious medical condition
Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
Uncontrollable infection
Previous allergic reactions in connection with paclitaxel and carboplatin
Subjects who participate another clinical trial within the last 4 weeks before inclusion

About this study

Official title: Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer

Read the detailed description

This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.

Conditions: Ovarian Cancer
Being tested: Genexol-PM 220mg/㎡, Carboplatin 5AUC, Genexol-PM 260mg/㎡, Carboplatin 5AUC, Genexol-PM 300mg/㎡, Carboplatin 5AUC
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 220mg/㎡, Carboplatin 5AUCDrug
Genexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
Genexol-PM 260mg/㎡, Carboplatin 5AUCDrug
Genexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
Genexol-PM 300mg/㎡, Carboplatin 5AUCDrug
Genexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.

Study groups in NCT00877253
Study group	Role	What they receive
Dose Level One	Experimental	Not described Receives: Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
Dose Level Two	Experimental	Not described Receives: Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
Dose Level Three	Experimental	Not described Receives: Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC

What is being measured

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

Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.
Measured: until either MTD is achieved or maximum planned dose is tested

Secondary outcomes (4)

Objective Response Rate (Complete Response (CR) + Partial Response (PR))
Measured: about 1 year (until end of trial)
Time to Tumor Progression
Measured: about 1 year (until end of trial)
Overall Survival
Measured: about 1 year (until end of trial)
Safety profiles
Measured: about 1 year (till end of trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Jun 2009

First posted7 Apr 2009 (estimated)
Study startMay 2008
Primary completionJun 2009
Study completionJun 2009

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00877253
Sponsor's protocol ID: GPMOC201
Status last verified: Jun 2012
First submitted: 3 Apr 2009
Last updated: 12 Jun 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
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The Vanguard Study: Testing a New Way to Screen for Cancer
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All Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
ClinicalTrials.gov ID: NCT00877253
Acronym / sponsor ID: GPMOC201
Conditions: Ovarian Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 7 Apr 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dose Level One	Experimental	Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
Dose Level Two	Experimental	Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
Dose Level Three	Experimental	Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Women ≥ 18 years old.
Signed informed consent before inclusion.
Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
Subjects who have measurable disease by RECIST after debulking surgery.
ECOG performance status of 0, 1, or 2.

Key exclusion criteria (12 listed)

Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
Subjects who have a history of radiotherapy to pelvis or abdominal cavity
Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
Subjects who have other malignancies within the past 5 years
Subjects who have had a major surgery other than debulking 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 220mg/㎡, Carboplatin 5AUCGenexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.	Drug	Dose Level One
Genexol-PM 260mg/㎡, Carboplatin 5AUCGenexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.	Drug	Dose Level Two
Genexol-PM 300mg/㎡, Carboplatin 5AUCGenexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.	Drug	Dose Level Three

Primary outcome

Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.
Time frame: until either MTD is achieved or maximum planned dose is tested

4 secondary outcomes

Objective Response Rate (Complete Response (CR) + Partial Response (PR))
Time frame: about 1 year (until end of trial)
Time to Tumor Progression
Time frame: about 1 year (until end of trial)
Overall Survival
Time frame: about 1 year (until end of trial)
Safety profiles
Time frame: about 1 year (till end of trial)

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 12 Jun 2012.

Related trials for Ovarian Cancer

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

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.

Soon Beom Kang, MD, PhD principal investigator

Seoul National University Hospital

Yong Man Kim, MD, PhD principal investigator

Asan Medical Center

Byoung Gie Kim, MD, PhD principal investigator

Samsung Medical Center

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 12 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 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer. (time frame: until either MTD is achieved or maximum planned dose is tested). 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 NCT00877253.

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 12 Jun 2012.