A Phase 1b, Open-Label, Safety, Pharmacokinetic, and Pharmacodynamic Study of an Anti-super-enhancer Minnelide Given Along With Abraxane Plus Gemcitabine in Patients With Metastatic Adenocarcinoma of the Pancreas

  • STATUS
    Recruiting
  • End date
    Dec 25, 2024
  • participants needed
    36
  • sponsor
    Minneamrita Therapeutics LLC
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Updated on 25 October 2022
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Summary

A Phase 1b, Open-Label, Safety, Pharmacokinetic, and Pharmacodynamic Study of an Anti-super-enhancer Minnelide Once a Day on Days 1 to 5, Days 8 to 12 and Days 15 to 19 Along with Abraxane Plus Gemcitabine in Patients with Metastatic Adenocarcinoma of the Pancreas

Description

Stressing the patient's pancreatic cancer by giving the anti-super-enhancer Minnelide to increase endoplasmic reticulum (ER) stress and improve the progression-free survival (PFS) when patients are treated with standard of care (SOC) nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) plus gemcitabine.

Details
Condition Metastatic Adenocarcinoma of the Pancreas
Treatment Minnelide
Clinical Study IdentifierNCT05557851
SponsorMinneamrita Therapeutics LLC
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

• Signed, written IRB-approved informed consent
Patients diagnosed with histologically confirmed metastatic adenocarcinoma of the pancreas combined with adenocarcinoma and adenosquamous are allowed, but pure adenosquamous patients are excluded
Disease progression while on FOLFIRINOX as first treatment
Had no prior treatment with nab-paclitaxel (Abraxane) plus gemcitabine or single agent nab-paclitaxel or gemcitabine or in any other combinations
Patient who has received prior or going to receive any killed vaccine including influenza, pneumococcal or COVID-19 during the study are allowed but any live vaccine like Herpes Zoster is not allowed. One or more metastatic tumours measurable on computed tomography (CT) scan per Response Evaluation Criteria in Solid Tumours (RECIST) V1.1 criteria excluding the primary pancreatic lesion
Karnofsky performance ≥ 70%
Life expectancy of at least 3 months, as determined by the Investigator
Age ≥ 19 years
A negative pregnancy test (if female)
Acceptable liver function as per below
Bilirubin ≤ 1.5 × upper limit of normal (ULN)
Aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT), serum glutamic pyruvic transaminase (SGPT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN (if liver metastases are present, then ≤ 5 × ULN is allowed)
Albumin ≥ 3.0 g/dL
Acceptable renal function as per below
Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Acceptable haematologic status
Baseline absolute neutrophil counts ≥ 2000 cells/mm3
Platelet count ≥ 100000 cells/mm3
Haemoglobin ≥ 9 g/dL
Urinalysis: No clinically significant abnormalities
Acceptable coagulation status in the absence of therapeutic intent to
anticoagulate
Prothrombin time (PT) ≤ 1.5 × institutional ULN
Partial thromboplastin time (PTT) ≤ 1.5 × institutional ULN
International normalised ratio (INR) ≤ 1.5 × institutional ULN. Note: Abnormal lab values will be retested once within 2 weeks
For men and women of childbearing potential, the use of effective contraceptive
methods during the study. From last dose effective contraception is to be
maintained as follows
Men: 100 days from last dose of MinnelideTM
Women of childbearing potential: 6 months from last dose of MinnelideTM
For females, agree to the use of two physician-approved contraceptive methods
(oral, injectable, or implantable hormonal contraceptive; tubal ligation
intra-uterine device; barrier contraceptive with spermicide; or vasectomised
partner) while on study IP, and for 3 months following the last dose of IP
Has negative serum pregnancy test (β-hCG) result at Screening
For males, must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy

Exclusion Criteria

• New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischaemia on ECG
Baseline QTc exceeding 470 msec (using the Bazett's formula) and/or patients receiving class 1A or class III antiarrhythmic agents. Note: If a single value of QTcB> 470 msec is observed which is not clinically significant as per the Investigator, triplicate ECGs should be performed and if the average QTcB ≤ 470 msec, then the patient can be included in the study
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Pregnant or nursing women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her PI immediately
Treatment with radiation therapy (local therapy, non target lesion within 2 weeks), major surgery, chemotherapy, biological agents, or investigational therapy within 3 weeks prior to study treatment
Unwillingness or inability to comply with procedures required in this protocol
Known infection with HIV, hepatitis B, or hepatitis C except for chronic hepatitis B or C patients with undetectable viral load
Serious non-malignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
Any other malignancy within 5 years prior to study drug administration, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment)
Patient with a history or current evidence of brain metastasis or leptomeningeal disease
Currently receiving any other investigational agent
On a prohibited medication (clarithromycin, loperamide, ondansetron, poly (ADP) - ribose polymerase inhibitors, programmed cell death protein 1 inhibitors, and tyrosine kinase inhibitors or immunotherapeutics)
Clear my responses
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