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 : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer, Adult||Drug: GP-2250||Phase 1 Phase 2|
In Phase 1 of the study, the dose-limiting toxicity (DLT) assessment period will be 5 weeks---one-week run-in at each dose level of intravenous GP-2250 monotherapy followed by a full cycle of GP-2250 plus gemcitabine (3 weeks on and 1 week off). Single-subject cohorts will be enrolled until the occurrence of the first DLT, at which point cohorts will be expanded to 3 subjects. If there are no DLTs observed within the first 3 single subject cohorts, there will be an expansion to 3 subject cohorts beginning with Cohort#4. Between single-subject cohorts, dose escalation increments of GP-2250 will be 100%. Beginning with the Cohort#4 further dose escalation increments between cohorts will be 35% to 45%. Subjects may continue to receive treatment until disease progression by Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria, clinical disease progression as assessed by the Investigator, development of a DLT (in Phase 1) or unacceptable toxicity, the subject requests withdrawal, the subject meets one of the criteria for treatment discontinuation, the Investigator determines the risks outweigh the benefits of continuing therapy, withdrawal of subject consent, or closure of the trial by the Sponsor.
In Phase 2, subjects will receive weekly doses of GP-2250 in combination with a standard dose of gemcitabine for 3 consecutive weeks (3 weeks on therapy and 1 week off). A Simon Two-Stage design will be used. In the first stage, 10 subjects will be enrolled. If at least 2 responses are observed, an additional 19 subjects will be enrolled. If at the end of the Phase 2 stage of the trial at least 6/29 responders are observed, it can be concluded that the response rate (RR) with GP 2250+gemcitabine is consistent with that of approximately 30%. Subjects may continue to receive treatment until withdrawn by the Investigator, the subject requests withdrawal, unacceptable toxicity occurs, the subject meets one of the criteria for treatment discontinuation, or disease progression, or closure of the trial by the sponsor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Bayesian Optimal Interval (BOIN); Simon 1 and 2|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 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 15, 2020|
|Estimated Study Completion Date :||February 1, 2021|
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.
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.
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, MDemail@example.com|
|Contact: Thomas Mueller, PhDfirstname.lastname@example.org|
|United States, Michigan|
|Quest Research Institute||Recruiting|
|Farmington Hills, Michigan, United States, 48334|
|Contact: Laura Nadeau, MD 248-267-6569 email@example.com|
|Study Chair:||Manuel Hildago, MD||Beth Israel Deaconess, Harvard|