Pancreatic Cancer Stage IVPhase 2NCT06518538
Evaluate Efficacy of Devimistat in Combination With mFFX in 2nd Line Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing CPI-613, modified Folfirinox in people with Pancreatic Cancer Stage IV, run by Cornerstone Pharmaceuticals at 1 site in United States.
Trial summary
Open label, randomized phase II study to evaluate efficacy and safety of CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Stage IV
- What is being tested?
- CPI-613, modified Folfirinox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to Nov 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic stage IV adenocarcinoma of the pancreas
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Male and female patients 18 - 75 years of age
- Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
- Recurrrence or progression while on FFX therapy.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must agree to use acceptable highly effective contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive(s), intrauterine hormone releasing system (IUS), bilateral tubal occlusion or vasectomized partner) during and for 6 months after last study dose and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
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- Males with female partners (of childbearing potential) and female partners (of childbearing potential) with male partners must agree to use double barrier contraceptive measure (a combination of male condom with either cap, diaphragm or sponge with spermicide) in addition to oral contraception, or avoidance of intercourse during the study and for 6 months after last study dose is received
- At least 4 weeks from major surgery with resolution of any sequela to date of enrollment
- Laboratory values ≤2 weeks during screening must be:
- Adequate hematologic values
- Platelet count ≥100,000 cells/mm3 or ≥100 bil/L;
- Absolute neutrophil count [ANC] ≥1,500 cells/mm3 or ≥1.5 bil/L;
- Hemoglobin >9 g/dL or >90 g/L
- Adequate hepatic function
- Aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL] (≤5xUNL if liver metastasis present)
- Alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastasis present)
- Bilirubin (≤1.5x UNL); bilirubin ≤ 2.5 x ULN for subjects with Gilbert's syndrome
- Adequate renal function
- Serum creatinine clearance CLcr > 30 mL/min). (Cockcroft-Gault Formula should be used for CrCl calculation)
- Adequate coagulation function
- International Normalized Ratio or INR must be <1.5 unless on anticoagulants
- No evidence of active infection and no serious infection within the past 30 days. Patient must have completed antibiotic course.
- Mentally competent, ability to understand and willingness to sign the informed consent form and follow protocol requirements
Who cannot join
- Endocrine or acinar pancreatic carcinoma
- Known cerebral metastasis, central nervous system (CNS), or epidural tumor
- Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
- Patients receiving any other investigational systemic agent for any indication within the past 2 weeks prior to initiation of devimistat treatment
- Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., Hemophilia A)
- Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of study treatment
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- Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at screening
- Male patients unwilling to abstain from donating sperm during treatment and for 6 months after completion of study treatment
- Active heart disease including but not limited to symptomatic congestive heart failure (NYHA class 3 or 4), symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction
- Patients with a history of myocardial infarction that is <3 months prior to registration
- Prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, in situ cancer, localized prostate cancer (Gleason score <8), or adequately treated cancer from which the patient has been disease-free for at least 3 years prior to screening
- Unwilling or unable to avoid the concomitant use of strong CYP3A4 inducers or inhibitors during treatment with irinotecan (Listed in the APPENDIX II: CYP3A4 Inducers or Inhibitors)
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 470 milliseconds (ms) (CTCAE grade 1) using Fridericia's QT correction formula (i.e. QTcF)
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
- The use of concomitant medications except anti-emetics that prolong the QT/QTc intervals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Single Center Open-Label Trial to Evaluate Efficacy and Safety of Devimistat in Combination With Modified FOLFIRINOX (mFFX) in 2nd Line Patients With Metastatic Adenocarcinoma of the Pancreas
Open label, randomized phase II study to evaluate efficacy and safety of CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years
- Conditions
- Pancreatic Cancer Stage IV
- Being tested
- CPI-613, modified Folfirinox
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-613, modified FolfirinoxDrug
- CPI-613, devimistat
- mFFX: Oxaliplatin, Folinic acid, Fluorouracil and Irinotecan
| Study group | Role | What they receive |
|---|---|---|
| CPI-613+mFFX | Experimental | Day 1: Devimistat at 500 mg/m2 IV infusion over 2 hours mFFX (given immediately after devimistat administration):
* Oxaliplatin at 60 mg/m2 given as a 2-hr IV infusion
* Folinic acid at 400 mg/m2 given as 30- 90 min infusion immediately after oxaliplatin, and concurrently with Irinotecan at 120 mg/m2 given as a 90-min ( IV infusion via a Y-connector.
* Fluorouracil (5-FU) 42-48-hr infusion at 2,200 mg/m2, starting immediately after completion of folinic acid and irinotecan
Day 2:
mFFX:
▪ Completing the remaining of the 5-FU 42-48-hr infusion starting on day 1
Day3:
mFFX: ▪ Completing the remaining of the 5-FU 42-48-hr infusion starting on day 1, 2 and disconnect the 5-FU pump
Devimistat:
▪ Devimistat (500 mg/m2), IV infusion over 2 hours via a central venous catheter after completion of 5-FU infusion.
Day 8:
Devimistat (500 mg/m2), IV infusion over 2 hours via a central venous catheter Receives: Drug: CPI-613, modified Folfirinox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) [Time Frame: At least 2 months (minimum of 4 cycles)] Defined as the rate of Complete Response (CR) plus Partial Response (PR)
Measured: 12 months
Secondary outcomes (2)
Overall Survival (OS) Defined as the duration from the date of randomization to the date of death from any cause
Measured: 24 months
Progression Free Survival (PFS) Defined as the duration from the date of randomization to the date of progressive defined as the duration from the date of randomization to the date of progressive disease or death from any cause.
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 posted24 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: due to study redesign
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Stage IVStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornerstone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518538
- Sponsor's protocol ID
- PANC004
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Single Center Open-Label Trial to Evaluate Efficacy and Safety of Devimistat in Combination With Modified FOLFIRINOX (mFFX) in 2nd Line Patients With Metastatic Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT06518538
- Acronym / sponsor ID
- PANC004
- Conditions
- Pancreatic Cancer Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to study redesign
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cornerstone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- 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.
Open label, randomized phase II study to evaluate efficacy and safety of CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPI-613+mFFX | Experimental | Drug: CPI-613, modified FolfirinoxDay 1: Devimistat at 500 mg/m2 IV infusion over 2 hours mFFX (given immediately after devimistat administration): * Oxaliplatin at 60 mg/m2 given as a 2-hr IV infusion * Folinic acid at 400 mg/m2 given as 30- 90 min infusion immediately after oxaliplatin, and concurrently with Irinotecan at 120 mg/m2 given as a 90-min ( IV infusion via a Y-connector. * Fluorouracil (5-FU) 42-48-hr infusion at 2,200 mg/m2, starting immediately after completion of folinic acid and irinotecan Day 2: mFFX: ▪ Completing the remaining of the 5-FU 42-48-hr infusion starting on day 1 Day3: mFFX: ▪ Completing the remaining of the 5-FU 42-48-hr infusion starting on day 1, 2 and disconnect the 5-FU pump Devimistat: ▪ Devimistat (500 mg/m2), IV infusion over 2 hours via a central venous catheter after completion of 5-FU infusion. Day 8: Devimistat (500 mg/m2), IV infusion over 2 hours via a central venous catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically or cytologically confirmed metastatic stage IV adenocarcinoma of the pancreas
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Male and female patients 18 - 75 years of age
- Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
- Recurrrence or progression while on FFX therapy.
Key exclusion criteria (15 listed)
- Endocrine or acinar pancreatic carcinoma
- Known cerebral metastasis, central nervous system (CNS), or epidural tumor
- Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
- Patients receiving any other investigational systemic agent for any indication within the past 2 weeks prior to initiation of devimistat treatment
- Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., Hemophilia A)
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 |
|---|---|---|
| CPI-613, modified Folfirinox* CPI-613, devimistat * mFFX: Oxaliplatin, Folinic acid, Fluorouracil and Irinotecan | Drug | CPI-613+mFFX |
Primary outcome
Overall Response Rate (ORR) [Time Frame: At least 2 months (minimum of 4 cycles)] Defined as the rate of Complete Response (CR) plus Partial Response (PR)
Time frame: 12 months
2 secondary outcomes
Overall Survival (OS) Defined as the duration from the date of randomization to the date of death from any cause
Time frame: 24 months
Progression Free Survival (PFS) Defined as the duration from the date of randomization to the date of progressive defined as the duration from the date of randomization to the date of progressive disease or death from any cause.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 CPI-613, modified Folfirinox in people with Pancreatic Cancer Stage IV, run by Cornerstone Pharmaceuticals at 1 site in United States.
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 23 inclusion and 15 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: withdrawn, as of the sponsor's last update on 15 Aug 2024. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall Response Rate (ORR) [Time Frame: At least 2 months (minimum of 4 cycles)] Defined as the rate of Complete Response (CR) plus Partial Response (PR) (time frame: 12 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 15 Aug 2024.