Is NCT06079346 recruiting in Houston, TX?

Yes, NCT06079346 is currently recruiting participants at its Houston, TX location. This pancreatic cancer clinical trial is actively enrolling qualified participants.

How do I join the pancreatic cancer clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pancreatic Cancer Clinical Trial in Houston, TX

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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.

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06079346) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pancreatic Cancer Treatment Options in Houston, TX

If you're searching for pancreatic cancer treatment options in Houston, TX, this clinical trial (NCT06079346) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this phase 2/3 clinical trial. You'll receive care from experienced pancreatic cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pancreatic cancer clinical trials near you to find additional studies recruiting in your area.

Pancreatic Cancer Clinical Trial in Houston, TX

Expert Care in Houston

IRB Approved

No-Cost Care

Apply for This Houston Location

Why Participate?

Simple Process

About This Pancreatic Cancer Study in Houston