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Trial record 1 of 1 for:    Geistlich | Pancreas Cancer
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Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine

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ClinicalTrials.gov Identifier: NCT03854110
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
Geistlich Pharma AG

Study Description
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Brief Summary:
This is a phase 1 first in human, dose escalation trial in subjects with advanced pancreatic cancer previously treated with FOLFIRINOX but never exposed to therapeutic gemcitabine.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer, Adult Drug: GP-2250 Phase 1

Detailed Description:
This trial used a Bayesian Optimal Interval (BOIN) dose escalation design of GP-2250 as a single-dose monotherapy (Cycle 1 only) followed by combination therapy with gemcitabine for Cohorts 1 through 5. Following implementation of Amendment 7 and beginning with dose Cohort 6 and all subsequent cohorts, the trial will use a 3+3 dose escalation design, and will continue as single-dose monotherapy (Cycle 1 only) followed by combination therapy with gemcitabine. Subjects will continue to receive treatment until disease progression assessed by RECIST V1.1 criteria, clinical disease progression as assessed by the Investigator, development of a dose limiting toxicity, unacceptable toxicity, subject request for withdrawal, Investigator assessment that risk outweighs benefit, or study closure by the Sponsor.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 3+3 dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of GP-2250 in Combination With Gemcitabine in Pancreatic Adenocarcinoma After FOLFIRINOX Chemotherapy
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GP-2250 Monotherapy
GP-2250 in doses of 250 mg up to 30 grams intravenously on Days -7, 1, 8, 15 of a 28 day cycle with gemcitabine 1000 mg/m2 on Days 1, 8, 15 days of the cycle.
 Drug: GP-2250
GP-2250 monotherapy for pharmacokinetics; GP-2250 plus gemcitabine for tolerability and biomarker assessments
Other Name: gemcitabine


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: 12-24 months ]
    Dose Limiting Toxicity - dose at which toxicity causes cessation of dose escalations.


Secondary Outcome Measures :
  1. Carbohydrate Antigen 19-9 (CA-19-9) [ Time Frame: 12-24 months ]
    A type of antigen released by pancreatic cancer cells and usually changes as disease progression or regressions occurs. Measurement of changes, if any, will be assessed in each patient.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Informed Consent:

  1. Capable of giving signed informed consent as described in Appendix 1: Regulatory, Ethical, and Trial Oversight Considerations which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

    Age:

  2. Male and female subjects age > 18 years at the time of trial entry. Type of Subject and Disease Characteristics
  3. Histologically or cytologically confirmed advanced unresectable or metastatic pancreatic adenocarcinoma
  4. Subjects should be eligible to receive gemcitabine monotherapy for the treatment of their pancreatic cancer per the judgment of the Investigator
  5. Subjects must have documented disease progression while receiving or within 3 months of completing prior treatment with FOLFIRINOX.
  6. Subjects must have at least one RECIST Version 1.1 defined measurable tumor lesion
  7. Subjects must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
  8. Subjects with known central nervous system metastasis must have undergone brain targeted treatment and must be asymptomatic or radiographically and clinically stable (including not requiring steroids or anti-seizure medications) for at least 4 weeks prior to enrollment.
  9. All subjects must consent to provide archived tumor specimens for biomarker studies.

  10. Subjects must have adequate organ function as indicated by the following laboratory values:

    1. Absolute neutrophil count (ANC) ≥ 1,500 /mL
    2. Platelets ≥ 100,000 / mL
    3. Hemoglobin ≥ 9 g/dL
    4. Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
    5. Serum total bilirubin ≤ 1.5 × ULN
    6. Aspartate aminotransferase (AST), (Serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT), and (Serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × ULN OR ≤ 5 × ULN for subjects with liver metastasis
    7. International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN
    8. Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
    9. Serum Albumin ≥ 3 gm/dL
  11. Female subjects of childbearing potential (woman of childbearing potential [WOCBP]) must have a negative serum pregnancy test.

  12. Subjects must use adequate contraception for the duration of the trial:

    1. Male subjects must agree to use a highly effective contraception during the treatment period and for at least 3 months after the last dose of trial intervention and refrain from donating sperm during this period
    2. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

Not a WOCBP:

OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of trial intervention.

Exclusion Criteria:

Medical Conditions:

  1. Diagnosis of any active malignancy other than pancreatic cancer within the past 2 years (not including non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of uterine cervix treated with curative intent).
  2. Subjects has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonia or multiple allergies, clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome with <=6 months prior to the start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or ascites requiring paracentesis in the 4 weeks prior to Screening.
  3. Any other medical, psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate and participate in the trial, or which would interfere with the interpretation of the results.
  4. Subject has undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  5. Prior history or current signs of hyphema or glaucoma.
  6. History of sickle cell disease or hereditary non-spherocytic hemolytic anemia.
  7. Baseline QTc interval >480 msec for female subjects or >450 msec for male subjects.
  8. Subject is unwilling or unable to comply with study procedures or is planning to take a vacation for 7 or more consecutive days during the source of the study.
  9. First degree relative of the investigator, study staff or the sponsor.

  10. Positive test for SARS-CoV2 (COVID-19) by polymerase chain reaction (PCR) testing within one week prior to Screening.

    Prior/Concomitant Therapy:

  11. Any chemotherapy administered within 3 weeks or 5 half-lives (whichever is shorter) before first dose of GP-2250; other anti-cancer therapy (including surgery, radiotherapy, immunotherapy, hormone therapy, or targeted therapy) administered within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GP-2250; or within 6 weeks in the case of certain therapies (mitomycin C and nitrosoureas).

    Prior/Concurrent Clinical Trial Experience:

  12. Investigational therapy administered within 4 weeks before the first dose of GP-2250.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854110


Contacts
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Contact: James C Costin, MD 12154508698 james.costin@panavance.com
Contact: Thomas Mueller, PhD +41414926808 thomas.mueller@geistlich.ch

Locations
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United States, California
Hoag Family Cancer Institute Recruiting
Newport Beach, California, United States, 92663
Contact: Diana Hanna, MD    949-764-6130    Diana.Hanna@med.usc.edu   
United States, Kansas
University of Kansas Cancer Center Recruiting
Fairway, Kansas, United States, 66205
Contact: Anup Kasi, MD    913-568-4085    akasi@kumc.edu   
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Andrea Bullock, MD    617-667-2100    abullock@bidmc.harvard.edu   
United States, Minnesota
Allina Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Joseph Leach, MD    612-863-8716    joseph.leach@usoncology.com   
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27292
Contact: Ravi Kumar Paluri, MD,MPH    336-713-3844    rpaluri@wakehealth.edu   
Contact: Annaleise Kennedy    336-73-6928    annkenne@wakehealth.edu   
Sponsors and Collaborators
Geistlich Pharma AG
Translational Drug Development
Investigators
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Study Chair: Anup Kasi, MD University of Kansas
More Information
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Publications:

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Responsible Party: Geistlich Pharma AG
ClinicalTrials.gov Identifier: NCT03854110    
Other Study ID Numbers: GP-2250-1001
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geistlich Pharma AG:
Disease progression on Folfirinox
Additional relevant MeSH terms:
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Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
 Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs