Pancreatic Ductal AdenocarcinomaPhase 2/3STOP-PCNCT06079346
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
A Phase 2/3 study testing OT-101 and mFOLFIRINOX in people with Pancreatic Ductal Adenocarcinoma, run by Oncotelic Inc. at 2 sites in United States.
Trial summary
The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- OT-101 and mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2024to 1 Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- A diagnosis of advanced and unresectable or metastatic pancreatic adenocarcinoma confirmed by:
- Histopathology from primary tumor in pancreas, OR
- Histopathology from a non-pancreatic lesion in the presence of a mass in the pancreas consistent with pancreatic adenocarcinoma or a medically documented history of pancreatic adenocarcinoma.
- Measurable disease per RECIST v.1.1
- Male or non-pregnant, non-lactating female, ≥18 years or age
- If a female patient is of child-bearing potential, as evidenced by menstrual periods, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β- hCG]) documented prior to the first administration of stud drugs
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- Female patients of childbearing age and women < 12 months since the onset of menopause must agree to use acceptable contraceptive methods for the duration of the study and 9 months following the last injection of OT-101.
- Male patients must use effective contraception for a duration of 6 months after the final dose, as per the prescribing information for oxaliplatin.
- Provide signed written informed consent
- Eastern Cooperative Group (ECOG) Performance Status (PS) score of 0-1
- Willingness and ability to comply with study requirements
- Patient has adequate organ function by the following laboratory assessments at baseline(obtained ≤28 days prior to Randomization):
- Hematologic
- Platelets ≥100×109/L
- Hemoglobin ≥9.0 g/dL
- Absolute Neutrophil Count (ANC) ≥1.5×109/L
- Patient has acceptable coagulation values obtained ≤28 days prior to Randomization as demonstrated by prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5× upper limit of normal (ULN) (if on Coumadin, patient must be changed to LMWH or on Factor II or Xa anticoagulant with a t½ of less than 24 hours
- Hepatic
- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3×ULN (if liver metastases are present, ≤5×ULN)
- Alkaline phosphatase ≤2.0×ULN (if liver metastases are present, ≤5×ULN)
- Total bilirubin ≤2.0×ULN (in patients with Gilbert's Syndrome total bilirubin < or = 2.5xULN)
- Renal
- Calculated creatinine clearance ≥50 mL/min. Actual body weight should be used for calculating creatinine clearance (e.g., using the Modification of Diet in Renal Disease [MDRD] formula. For patients with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead
- Patient must have a life expectancy of ≥3 months in the opinion of the Investigator
Who cannot join
- Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (ie,lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
- Patient has experienced a decrease in ECOG PS between Screening visit and within 72 hours prior to Randomization
- Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with t½ of less than 24 hours
- History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (eg, breast and prostate) for which the patient has been disease-free for at least 3 years. Patients with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study
- Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for the study
- Patients with abnormal electrocardiogram (ECG) at baseline (QT or QTc interval >470 ms) will be excluded from this study. The eligibility of patients with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the Sponsor's medical representative in consultation with the principal investigator.
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- Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
- Known history of positivity (regardless of immune status) for human immunodeficiency virus(HIV)
- Known history of chronic active or active viral hepatitis A, B, or C infection
- Clinically significant bleeding within 2 weeks prior to Randomization (eg, gastrointestinal[GI] bleeding or intracranial hemorrhage)
- Pregnant or lactating women
- Myocardial infarction, coronary bypass surgery, or arterial thromboembolic events within the last 6 months prior to Randomization, symptomatic congestive heart failure (New York Heart Association Classification >Class II, unstable angina, or unstable cardiac arrhythmia requiring medication
- Clinically significant ascites defined as requiring ≥1 paracentesis every 2 weeks
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to Randomization or anticipated surgery during the study period
- Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1, anti-PD-L1)
- Peripheral neuropathy (>Grade 1)
- Known history of dihydropyrimidine dehydrogenase deficiency (DPD) - Dihydropyrimidine dehydrogenase (DPD) is the initial and rate-limiting enzyme in the catabolism of 5-fluorouracil (5-FU). Thus, patients with a DPD deficiency are at risk of developing severe 5-FU-associated toxicity
- History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner´s granulomatosis, Sjogren´s syndrome, Bell´s palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism
- Patients receiving any of the following medications are not eligible for study:
- Investigational agents other than the protocol drugs
- Anti-coagulants (except for heparin to maintain the patency of central venous catheters)
- Non-steroidal anti-inflammatory drugs
- Clopidogrel (Plavix), dipyridamole (Persantine), or any other drug that inhibits platelet functions
- Patients on greater than 2 mg dexamethasone, 10 mg Prednisone or or equivalent dose in alternate corticosteroid daily or actively undergoing corticosteroid dose escalation are NOT eligible
- History of allergic reactions or known hypersensitivity to compounds of similar chemical or biologic composition to OT-101 such as anti-sense oligonucleotides or siRNA
- Patients who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy. Telemedicine visits are acceptable
- Not willing and able to comply with study requirements including protocol mandated procedures and visits
- Other contraindications as defined in the product label of the components of the mFOLFIRINOX treatment regimen
- Participation in another investigational clinical trial within 30 days of receiving the last dose of investigational study drug
- Clinically significant psychiatric disorders, legal incapacity or limited legal capacity
- Patients with a primary immunodeficiency
- Patients with active central nervous system (CNS) metastases. (Patients with adequately treated CNS metastases who are clinically stable for at least 6 weeks after discontinuation of corticosteroids may be eligible for enrollment with the approval of the Sponsor's medical representative and the principal investigator)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Karmanos Cancer Center
Detroit, Michigan, 48201
Anthony Shields, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Shalini Makawita, MD
About this study
Official title: A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.
Read the detailed description
OT-01-P201 is designed as a randomized, open-label, active controlled, multicenter Phase 2B/Phase 3 study designed to compare the efficacy and safety of OT-101 in combination with modified FOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to modified FOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer. The primary endpoint of the study is overall survival and key secondary endpoints are progression-free survival and objective response rate.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- OT-101, mFOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-101Drug
OT-101: antisense oligodeoxynucleotide complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene
mFOLFIRINOXDrug
Folinic acid, 5-FU, Irinotecan, Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| OT-101 + mFOLFIRINOX | Active comparator | OT-101 IV dosed on Days 4-7 plus mFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle Receives: Drug: OT-101; Drug: mFOLFIRINOX |
| mFOLFIRINOX Only | Placebo comparator | mFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle Receives: Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
To compare the efficacy of OT-101 in combination with mFOLFIRINOX versus mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer as measured by overall survival (OS)
Measured: 2.5 years
Secondary outcomes (5)
Pharmacokinetic (PK) Parameter - Area Under the Curve (AUC)
To characterize the area under the curve (AUC) of OT-101 when it is combined with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer. Area under the curve is a measure of how much a drug reaches a person's bloodstream in a given period of time after a dose is given.
Measured: 1 year
Pharmacokinetic (PK) Parameter - Cmax
To characterize the Cmax of OT-101 when it is combined with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer. Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.
Measured: 1 year
Progression-Free Survival (PFS)
To assess the efficacy of OT-101 in combination with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer as measured by Progression-free survival (PFS)
Measured: 2.5 years
Objective Response Rate (ORR)
To assess the efficacy of OT-101 in combination with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer as measured by Objective Response Rate (ORR)
Measured: 2.5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To compare the incidence of treatment-emergent adverse events of OT-101 in combination with mFOLFIRINOX versus mFOLFIRINOX alone
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 May 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 455 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncotelic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079346
- Sponsor's protocol ID
- OT-01-P201
- Acronym
- STOP-PC
- Status last verified
- May 2024
- First submitted
- 29 Sep 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06079346
- Acronym / sponsor ID
- STOP-PC / OT-01-P201
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 455 participants (estimated)
- Lead sponsor
- Oncotelic Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Oct 2023 (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.
The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.
Detailed description
OT-01-P201 is designed as a randomized, open-label, active controlled, multicenter Phase 2B/Phase 3 study designed to compare the efficacy and safety of OT-101 in combination with modified FOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to modified FOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer. The primary endpoint of the study is overall survival and key secondary endpoints are progression-free survival and objective response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT-101 + mFOLFIRINOX | Active comparator | Drug: OT-101, Drug: mFOLFIRINOXOT-101 IV dosed on Days 4-7 plus mFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle |
| mFOLFIRINOX Only | Placebo comparator | Drug: mFOLFIRINOXmFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- A diagnosis of advanced and unresectable or metastatic pancreatic adenocarcinoma confirmed by:
- Measurable disease per RECIST v.1.1
- Male or non-pregnant, non-lactating female, ≥18 years or age
- Provide signed written informed consent
- Eastern Cooperative Group (ECOG) Performance Status (PS) score of 0-1
Key exclusion criteria (32 listed)
- Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (ie,lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
- Patient has experienced a decrease in ECOG PS between Screening visit and within 72 hours prior to Randomization
- Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with t½ of less than 24 hours
- History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (eg, breast and prostate) for which the patient has been disease-free for at least 3 years. Patients with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study
- Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for the study
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 |
|---|---|---|
| OT-101OT-101: antisense oligodeoxynucleotide complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene | Drug | OT-101 + mFOLFIRINOX |
| mFOLFIRINOXFolinic acid, 5-FU, Irinotecan, Oxaliplatin | Drug | OT-101 + mFOLFIRINOX, mFOLFIRINOX Only |
Primary outcome
Overall Survival (OS)
Time frame: 2.5 years
To compare the efficacy of OT-101 in combination with mFOLFIRINOX versus mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer as measured by overall survival (OS)
5 secondary outcomes
Pharmacokinetic (PK) Parameter - Area Under the Curve (AUC)
Time frame: 1 year
Pharmacokinetic (PK) Parameter - Cmax
Time frame: 1 year
Progression-Free Survival (PFS)
Time frame: 2.5 years
Objective Response Rate (ORR)
Time frame: 2.5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OT-101 and mFOLFIRINOX in people with Pancreatic Ductal Adenocarcinoma, run by Oncotelic Inc. at 2 sites 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 24 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 13 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 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Lee, PhD ((650) 635-7024, clee@oncotelic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 2.5 years). 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 13 Aug 2024.