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Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma

Phase I Study of Proglumide With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic DuctalAdenocarcinoma

NCT06017323•Georgetown University

View on ClinicalTrials.gov

Summary

This is a Phase I open labelled study to treat patients with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with gemcitabine and nab-paclitaxel given days 1, 8, and 15 every 28 days, and proglumide. This is a phase 1 study with 3+3 design, enrolling3-12 patients over 2 planned dose levels of proglumide(maximum 6 patients per dose level). Proglumide will be tested at the daily dose of 1200 mg orally (PO) given as 400mg three times daily (TID) (dose level 1) or 1600 mg orally(PO) given as 800 mg twice a day (BID) (dose level 2). All cycles are 28 days. Patients will be monitored for safety and toxicity by laboratory blood testing and physical examinations.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
•2. Age \> 18 years at time of study entry.
•3. Adequate normal organ and marrow function as defined below:
•* Hemoglobin ≥ 9.0 g/dL
•* Absolute neutrophil count (ANC) \> 1500 permm3
•* Platelet count ≥100,000 per mm3)
•* Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).
•* Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5 x ULN of normal unless liver metastases are present, in which case it must be ≤5x ULN
•* Creatinine clearance (CL) \>60 mL/min using the Cockcroft-Gault formula.
•4. Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
+6 more criteria

Exclusion Criteria

•1. Subjects with a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer, or localized prostate cancer following definitive therapy.
•2. Subjects with uncontrolled cardiovascular diseases(congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias) or who have suffered a myocardial infarction in the preceding 6months.
•3. Blood anticoagulation that cannot be safely stopped for biopsy.
•4. Subjects with poorly controlled medical conditions including asthma, chronic obstructive pulmonary disease, diabetes, seizure disorders, hepatic or renal failure.
•5. Pregnant or nursing women.
•6. Men or women of childbearing potential who are unwilling to employ adequate contraception(condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence) prior to study entry, for the duration of study participation, and for 6 months thereafter.
•7. Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment.
•8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
•9. History of allogenic organ transplantation.
•10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea or inability to digest and absorb pills, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring Adverse Events (AEs) or compromise the ability of the patient to give written informed consent
+8 more criteria

Locations (1)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, United States

Key Dates

Start Date

October 1, 2023

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

October 25, 2023

Conditions

Metastatic Pancreatic Cancer

Interventions

Gemcitabine

DRUG

Nab paclitaxel

DRUG

Proglumide Dose level 1

DRUG

Proglumide Dose level 2

DRUG

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

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Pancreatic CancerMetastatic Pancreatic Cancer+1 more

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RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

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Metastatic Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer