Non Small Cell Lung CancerPhase 2NCT01023347
A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
A Phase 2 study testing Paclitaxel (Genexol®) and Paclitaxel loaded polymeric micelle (Genexol-PM®) in people with Non Small Cell Lung Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Paclitaxel (Genexol®) and Paclitaxel loaded polymeric micelle (Genexol-PM®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv)
- At least one measurable lesion(s) by RECIST criteria
- No previous palliative chemotherapy
- Age 18 or higher.
- ECOG PS 0-2
- Life expectancy of at least 3 months.
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- Adequate hematologic, hepatic, renal function
- Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul)
- Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5 upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit)
- Adequate renal function (≤ serum creatinine 1.5 mg/dl)
- Written informed consent
Who cannot join
- No prior chemotherapy for NSCLC
- Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
- Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0)
- Clinically significant cardiac disease (medically uncontrollable heart disease)
- Active infection or other serious medical illness
- Contraindication to any drug contained in the chemotherapy regimen
- Pregnant or lactating women were excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Jung-gu, 301-721
About this study
This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Paclitaxel (Genexol®), Paclitaxel loaded polymeric micelle (Genexol-PM®)
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel (Genexol®)Drug
Paclitaxel loaded polymeric micelle (Genexol-PM®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel (Genexol®) and Cisplatin | Active comparator | Not described Receives: Drug: Paclitaxel (Genexol®) |
| Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin | Experimental | Not described Receives: Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
overall responses are complete response and partial response
Measured: up to 6 cycles
Secondary outcomes (3)
overall survival
OS was calculated by the time from randomization date to the date of death
Measured: up to 3 years
progression-free survival
PFS was calculated by the time from randomization date to objective tumor progression or death.
Measured: up to 3 years
toxicity profiles
Incidence of AE, laboratory test results (hematology, blood chemistry, and urine test), physical examination, vital sign, and ECOG performance were used for safety endpoints
Measured: up to 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung 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
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun Young Kim, Ph.D., Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023347
- Sponsor's protocol ID
- GPM-0801
- Status last verified
- May 2017
- First submitted
- 30 Nov 2009
- Last updated
- 9 May 2017
- Results posted
- No
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 of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01023347
- Acronym / sponsor ID
- GPM-0801
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2008 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Dec 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.
This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel (Genexol®) and Cisplatin | Active comparator | Drug: Paclitaxel (Genexol®) |
| Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin | Experimental | Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv)
- At least one measurable lesion(s) by RECIST criteria
- No previous palliative chemotherapy
- Age 18 or higher.
- ECOG PS 0-2
Key exclusion criteria (7 listed)
- No prior chemotherapy for NSCLC
- Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
- Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0)
- Clinically significant cardiac disease (medically uncontrollable heart disease)
- Active infection or other serious medical illness
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 |
|---|---|---|
| Paclitaxel (Genexol®) | Drug | Paclitaxel (Genexol®) and Cisplatin |
| Paclitaxel loaded polymeric micelle (Genexol-PM®) | Drug | Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin |
Primary outcome
response rate
Time frame: up to 6 cycles
overall responses are complete response and partial response
3 secondary outcomes
overall survival
Time frame: up to 3 years
progression-free survival
Time frame: up to 3 years
toxicity profiles
Time frame: up to 6 cycles
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.
Sun Young Kim, Ph.D. principal investigator
Chungnam National University Hospital
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 Paclitaxel (Genexol®) and Paclitaxel loaded polymeric micelle (Genexol-PM®) in people with Non Small Cell Lung 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 11 inclusion and 7 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?
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.