Metastatic Pancreatic AdenocarcinomaPhase 1/2GABRINOXNCT01964287
First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.
A Phase 1/2 study testing GEMBRAX and FOLFIRINOX in people with Metastatic Pancreatic Adenocarcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- GEMBRAX and FOLFIRINOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2013to 30 Dec 2020
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the radiologic data.
- Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.
- One or more metastatic tumors measurable metastatic lesions by CT scan of the abdomen, pelvis and chest, or hepatic MRI and CT scan (abdomen, pelvis and chest) without injection, if patient is allergic to CT contrast media).
- No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
- Prior treatment with 5 FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided that at least 6 months have relapsed since completion of the last dose and no lingering toxicities are present.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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- Males or females aged 18 to 75 years at the time of signing the Informed Consent Form (ICF).
- Adequate blood function at baseline (obtained within 14 days before start of study treatment)
- Adequate liver and renal function at baseline (obtained within 14 days before start of study treatment)
- Patient has no clinical significant abnormalities in urinalysis results (obtained ≤ 14 days before start of study treatment)
- Patient has acceptable coagulation values (obtained ≤14 days prior to the first administration of study drug)
- Patient should be asymptomatic for jaundice prior to the first administration of study drug (Day1). Significant or symptomatic amounts of ascites should be drained prior to Day 1.
- Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1 of treatment.
- Life expectancy ≥ 2 months
- Non-pregnant and non-lactating female. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β-hCG) documented 72 hours prior to randomization.
- If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.
- Informed consent signed prior to any study specific procedures.
- Affiliated to the French National social security
Who cannot join
- Known brain metastases.
- Patient has only locally advanced disease.
- History of other 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 having received cytotoxic doses of any other chemotherapy (than 5FU and gemcitabine) in the adjuvant setting.
- Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF.
- Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
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- Known historical or active infection with HIV.
- Major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- History of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the SmPCs or Prescribing Information.
- History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
- Patients with high cardiovascular risk, including, but not limited to, coronary stenting or myocardial infarction in the past year.
- History of Peripheral Artery Disease (e.g. claudication, Leo Buerger's disease).
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- Enrollment in any other clinical protocol within 4 weeks of signing the ICF.
- Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.
- Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to complete the study or sign the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I-II Trial of Gemcitabine Plus Nab-paclitaxel (GemBrax) Followed by Folfirinox as First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.
Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate.
Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.
Read the detailed description
Estimated enrollment:
Phase I: 60 Phase II: 53
Study start Date: August 2013 Estimated study completion date: March 2016
Treatment:
Gembrax: albumin-bound paclitaxel over 30 minutes IV followed by Gemcitabine 10mg/m²/min IV on day 1, 8 and 15 followed by 2 weeks of rest Folfirinox: Oxaliplatin IV associated with LeucovorinIV. After the end of leucovorin administration, bolus injection of 5FU and subsequent continuous 5FU 46-hour infusion at day 29 and 43.
Day 1=Day 57
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- GEMBRAX, FOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEMBRAXDrug
Also called Albumin bound paclitaxel 125 mg/m², Gemcitabine 1000 mg/m²
FOLFIRINOXDrug
Also called Oxaliplatin 85 mg/m², Irinotecan 180 mg/m², Leucovorin 200 mg/m², 5FU bolus 400mg/m²
| Study group | Role | What they receive |
|---|---|---|
| Gembrax followed by Folfirinox | Experimental | Gembrax:
Albumin-bound paclitaxel followed by Gemcitabine Day 1,8,15 followed by 2 weeks of rest
Folfirinox:
Oxaliplatin, irinotecan, leucovorin, 5FU bolus and continuous Receives: Drug: GEMBRAX; Drug: FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the MTD
Phase I: Identify the maximum tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metatstatic pancreatic adenocarcinoma.
Phase II: Objective response rate of patients treated with this new combination
Measured: 18 months
Secondary outcomes (1)
Overall survival
evaluate the safety profile
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start24 Sep 2013
- Primary completion22 Dec 2016
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964287
- Sponsor's protocol ID
- VA2012/25
- Acronym
- GABRINOX
- Status last verified
- Dec 2020
- First submitted
- 5 Aug 2013
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Trial of Gemcitabine Plus Nab-paclitaxel (GemBrax) Followed by Folfirinox as First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT01964287
- Acronym / sponsor ID
- GABRINOX / VA2012/25
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 24 Sep 2013 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 Oct 2013 (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.
Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate.
Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.
Detailed description
Estimated enrollment:
Phase I: 60 Phase II: 53
Study start Date: August 2013 Estimated study completion date: March 2016
Treatment:
Gembrax: albumin-bound paclitaxel over 30 minutes IV followed by Gemcitabine 10mg/m²/min IV on day 1, 8 and 15 followed by 2 weeks of rest Folfirinox: Oxaliplatin IV associated with LeucovorinIV. After the end of leucovorin administration, bolus injection of 5FU and subsequent continuous 5FU 46-hour infusion at day 29 and 43.
Day 1=Day 57
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gembrax followed by Folfirinox | Experimental | Drug: GEMBRAX, Drug: FOLFIRINOXGembrax: Albumin-bound paclitaxel followed by Gemcitabine Day 1,8,15 followed by 2 weeks of rest Folfirinox: Oxaliplatin, irinotecan, leucovorin, 5FU bolus and continuous |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the radiologic data.
- Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.
- One or more metastatic tumors measurable metastatic lesions by CT scan of the abdomen, pelvis and chest, or hepatic MRI and CT scan (abdomen, pelvis and chest) without injection, if patient is allergic to CT contrast media).
- No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
- Prior treatment with 5 FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided that at least 6 months have relapsed since completion of the last dose and no lingering toxicities are present.
Key exclusion criteria (16 listed)
- Known brain metastases.
- Patient has only locally advanced disease.
- History of other 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 having received cytotoxic doses of any other chemotherapy (than 5FU and gemcitabine) in the adjuvant setting.
- Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF.
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 |
|---|---|---|
| GEMBRAXAlso: Albumin bound paclitaxel 125 mg/m², Gemcitabine 1000 mg/m² | Drug | Gembrax followed by Folfirinox |
| FOLFIRINOXAlso: Oxaliplatin 85 mg/m², Irinotecan 180 mg/m², Leucovorin 200 mg/m², 5FU bolus 400mg/m² | Drug | Gembrax followed by Folfirinox |
Primary outcome
Determination of the MTD
Time frame: 18 months
Phase I: Identify the maximum tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metatstatic pancreatic adenocarcinoma. Phase II: Objective response rate of patients treated with this new combination
1 secondary outcome
Overall survival
Time frame: 12 months
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 31 Dec 2020.
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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 1/2 study testing GEMBRAX and FOLFIRINOX in people with Metastatic Pancreatic Adenocarcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 18 inclusion and 16 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 31 Dec 2020. 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 France. 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 combined 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.
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?
Determination of the MTD (time frame: 18 months). 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 31 Dec 2020.