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

Arm | Intervention/treatment |
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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.
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Drug: GP-2250
GP-2250 monotherapy for pharmacokinetics; GP-2250 plus gemcitabine for tolerability and biomarker assessments
Other Name: gemcitabine |
- Dose Limiting Toxicity (DLT) [ Time Frame: 12-24 months ]Dose Limiting Toxicity - dose at which toxicity causes cessation of dose escalations.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Informed Consent:
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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:
- Male and female subjects age > 18 years at the time of trial entry. Type of Subject and Disease Characteristics
- Histologically or cytologically confirmed advanced unresectable or metastatic pancreatic adenocarcinoma
- Subjects should be eligible to receive gemcitabine monotherapy for the treatment of their pancreatic cancer per the judgment of the Investigator
- Subjects must have documented disease progression while receiving or within 3 months of completing prior treatment with FOLFIRINOX.
- Subjects must have at least one RECIST Version 1.1 defined measurable tumor lesion
- Subjects must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
- 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.
- All subjects must consent to provide archived tumor specimens for biomarker studies.
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Subjects must have adequate organ function as indicated by the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1,500 /mL
- Platelets ≥ 100,000 / mL
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
- Serum total bilirubin ≤ 1.5 × ULN
- 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
- International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN
- Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
- Serum Albumin ≥ 3 gm/dL
- Female subjects of childbearing potential (woman of childbearing potential [WOCBP]) must have a negative serum pregnancy test.
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Subjects must use adequate contraception for the duration of the trial:
- 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
- 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:
- 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).
- 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.
- 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.
- 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.
- Prior history or current signs of hyphema or glaucoma.
- History of sickle cell disease or hereditary non-spherocytic hemolytic anemia.
- Baseline QTc interval >480 msec for female subjects or >450 msec for male subjects.
- 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.
- First degree relative of the investigator, study staff or the sponsor.
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Positive test for SARS-CoV2 (COVID-19) by polymerase chain reaction (PCR) testing within one week prior to Screening.
Prior/Concomitant Therapy:
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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:
- Investigational therapy administered within 4 weeks before the first dose of GP-2250.

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
Contact: James C Costin, MD | 12154508698 | james.costin@panavance.com | |
Contact: Thomas Mueller, PhD | +41414926808 | thomas.mueller@geistlich.ch |
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 |
Study Chair: | Anup Kasi, MD | University of Kansas |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Disease progression on Folfirinox |
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 |