Recurrent Adenocarcinoma of the PancreasPhase 2NCT02739633
Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
A Phase 2 study testing Genexol-PM and Gemcitabine in people with Recurrent Adenocarcinoma of the Pancreas and Metastatic Adenocarcinoma of the Pancreas, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Recurrent Adenocarcinoma of the Pancreas, Metastatic Adenocarcinoma of the Pancreas
- What is being tested?
- Genexol-PM and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
- Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
- Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
- Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
- Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
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- Platelet count ≥ 100,000/mm3 (100 × 10^9/L)
- Hemoglobin (Hgb) ≥ 9 g/dL.
- Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
- AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed.
- Total bilirubin ≤ULN
- Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
- Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Who cannot join
- History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- Patients have uncontrolled bacterial, viral, or fungal infections
- Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
- Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
- Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.
- History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
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
Hyun Woo Lee, M.D
About this study
Official title: Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.
Read the detailed description
The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.
- Being tested
- Genexol-PM, Gemcitabine
- Keywords
- Chemotherapy, Gemcitabine, Recurrent and metastatic adenocarcinoma of the pancreas, Genexol-PM, Paclitaxel
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genexol-PMDrug
Also called Cremorphor EL-free paclitaxel
125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
GemcitabineDrug
1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Genexol-PM + Gemcitabine | Experimental | Genexol-PM125 mg/m2 will be administered in combination with gemcitabine 1,000 mg/m2 weekly for 3 weeks followed by one week of rest. Each cycle is 28 days. Receives: Drug: Genexol-PM; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) as assessed by RECIST.
ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines.
Response is confirmed at least 4 weeks later.
Measured: 8 weeks
Secondary outcomes (4)
Progression free survival (PFS)
Time from the date of enrollment until the date of objective disease progression or the date of death.
PFS will be summarized using Kaplan-Meier methods.
Measured: 2 years
Overall survival (OS)
OS will be summarized using Kaplan-Meier methods.
Measured: 2 years
Disease control rate (DCR)
DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease
Measured: 8 weeks
Number of participants with adverse events
A adverse event (AE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 21 days after the last dose of the last study drug.
Severity grades according to NCI CTCAE version 4.0.
Measured: Baseline up to Day 21 after the last dose of study treatment
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 completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adenocarcinoma of the PancreasStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyun Woo Lee, M.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739633
- Sponsor's protocol ID
- Genexol-PM PC
- Status last verified
- Apr 2018
- First submitted
- 21 Mar 2016
- Last updated
- 18 Apr 2018
- 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 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT02739633
- Acronym / sponsor ID
- Genexol-PM PC
- Keywords
- Chemotherapy, Gemcitabine, Recurrent and metastatic adenocarcinoma of the pancreas, Genexol-PM, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (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.
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.
Detailed description
The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genexol-PM + Gemcitabine | Experimental | Drug: Genexol-PM, Drug: GemcitabineGenexol-PM125 mg/m2 will be administered in combination with gemcitabine 1,000 mg/m2 weekly for 3 weeks followed by one week of rest. Each cycle is 28 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
- Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
- Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
- Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
- Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization):
Key exclusion criteria (6 listed)
- History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- Patients have uncontrolled bacterial, viral, or fungal infections
- Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
- Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
- Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 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 |
|---|---|---|
| Genexol-PMAlso: Cremorphor EL-free paclitaxel125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. | Drug | Genexol-PM + Gemcitabine |
| Gemcitabine1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. | Drug | Genexol-PM + Gemcitabine |
Primary outcome
Objective response rate (ORR) as assessed by RECIST.
Time frame: 8 weeks
ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines. Response is confirmed at least 4 weeks later.
4 secondary outcomes
Progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 8 weeks
Number of participants with adverse events
Time frame: Baseline up to Day 21 after the last dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- 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.
Hyun Woo Lee, M.D. principal investigator
Ajou University School of Medicine
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 and Gemcitabine in people with Recurrent Adenocarcinoma of the Pancreas and Metastatic Adenocarcinoma of the Pancreas, 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 13 inclusion and 6 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 18 Apr 2018. 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?
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?
Objective response rate (ORR) as assessed by RECIST. (time frame: 8 weeks). 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 18 Apr 2018.