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Metastatic Pancreatic CancerPhase 1ProglumidePancNCT06017323

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

A Phase 1 study testing Gemcitabine, Nab paclitaxel and Proglumide Dose level 1 in people with Metastatic Pancreatic Cancer, run by Georgetown University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Gemcitabine, Nab paclitaxel and Proglumide Dose level 1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2023to Jul 2026
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Age > 18 years at time of study entry.
  • 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)
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  • 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.
  • 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:
  • -Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments, or if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization(bilateral oophorectomy or hysterectomy).
  • Patients must have measurable disease by RECIST v1.1 and disease amenable to serial biopsy.
  • Subjects may not have received prior therapy with Gemcitabine (GEM)/Nab-paclitaxel (NAB-P).
  • Patients must have metastatic pancreatic ductal adenocarcinoma with adenocarcinoma as the dominant histology (biopsy-proven, primary tumor biopsy is acceptable for eligibility)
  • No prior systemic treatment for metastatic disease(neoadjuvant/adjuvant therapy is allowable but could not contain GEM or NAB-P).
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • 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.
  • 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.
  • Blood anticoagulation that cannot be safely stopped for biopsy.
  • Subjects with poorly controlled medical conditions including asthma, chronic obstructive pulmonary disease, diabetes, seizure disorders, hepatic or renal failure.
  • Pregnant or nursing women.
  • 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.
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  • Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment.
  • 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.
  • History of allogenic organ transplantation.
  • 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
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and Tuberculosis (TB) testing in line with local practice), hepatitis B (HBV) (known positive HBV surface antigen (HBsAg) result), hepatitis C (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies).
  • Patients with a past or resolved HBV infection(defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
  • Patients positive for hepatitis C (HCV)antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Testing for tuberculosis, hepatitis B and C and HIV is not a requirement for screening for the clinical trial.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational drug. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of proglumide therapy.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Patient is unable to swallow pills or has a malabsorption syndrome that would not enable the patient to properly absorb proglumide.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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

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.

Being tested
Gemcitabine, Nab paclitaxel, Proglumide Dose level 1, Proglumide Dose level 2
Keywords
Proglumide, Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called Gemzar

    1000mg/m2 IV given days 1, 8, and 15every 28 days (1 cycle)

  • Nab paclitaxelDrug

    125 mg/m2 given days 1, 8, and 15every 28 days (1 cycle)

  • Proglumide Dose level 1Drug

    Daily dose of 1200 mg orally given as400 mg orally (PO), three times a day(TID) (dose level 1)

  • Proglumide Dose level 2Drug

    Daily dose of 1600 mg orally given as800 mg orally (PO) twice a day (BID)(dose level 2).

Study groups in NCT06017323
Study groupRoleWhat they receive
Dose Level 1:Proglumide TID with Gemcitabine and Nab-PaclitaxelExperimentalProglumide given three times a day with gemcitabine and nab-paclitaxel
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Proglumide Dose level 1
Dose Level 2:Proglumide BID with Gemcitabine and Nab-PaclitaxelExperimentalProglumide given two times a day with gemcitabine and nab-paclitaxel
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Proglumide Dose level 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proglumide Recommended Phase II dose and schedule (RP2D)

    Determination of the recommended phase II dose and schedule (RP2D) of proglumide in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma

    Measured: 2 years

Secondary outcomes (4)

  1. Overall survival (OS)

    median overall survival will be estimated using Kaplan-Meier curves.

    Measured: through 2 years after end of treatment

  2. Progression-free survival

    median progression free survival will be estimated using Kaplan-Meier curves.

    Measured: 2 years

  3. Objective response rate by RECIST v. 1.1

    Every 8 weeks (± 7 days) radiographic imaging (CT or MRI) will be done to assess tumor burden according to RECIST v. 1.1

    Measured: 2 years

  4. Change in tumor marker (CA19-9)

    Maximum percent decrease in CA19-9 will be analyzed.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Why it stopped: STUDY00006987

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017323
Sponsor's protocol ID
STUDY00001899
Acronym
ProglumidePanc
Status last verified
Oct 2023
First submitted
24 Aug 2023
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Nab paclitaxel and Proglumide Dose level 1 in people with Metastatic Pancreatic Cancer, run by Georgetown University 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 16 inclusion and 18 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 25 Oct 2023. 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 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.

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?

Proglumide Recommended Phase II dose and schedule (RP2D) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017323.

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 25 Oct 2023.

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