Multicenter Trial of ESK981 in Patients With Select Solid Tumors
- Conditions
- Pancreatic AdenocarcinomaAdenosquamous CarcinomaPancreatic Neuroendocrine TumorPancreatic Neuroendocrine CarcinomaGastrointestinal Neuroendocrine TumorGastrointestinal Neuroendocrine CarcinomaNeuroendocrine Prostate Carcinoma
- Interventions
- Registration Number
- NCT05988918
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 \> 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients.
Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 ESK981 Pancreatic adenocarcinoma Cohort 2 ESK981 Pancreatic or gastrointestinal neuroendocrine neoplasms with Ki-67 \> 20% Cohort 3 ESK981 Neuroendocrine prostate carcinoma with Ki-67 \> 20%
- Primary Outcome Measures
Name Time Method Progression Free Survival 4 months after initiating study drug Determining efficacy using proportion of patients alive and progression-free at 4 months within each cancer subtype
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) within each cancer subtype up to 18 months from treatment discontinuation The OS will be defined from the date of treatment to either date of death or censoring and estimated using the product-limit method of Kaplan and Meier. Follow-up time will be censored at the date of last disease evaluation.
Overall Response Rate (ORR) within each cancer subtype up to 18 months from treatment discontinuation The ORR will be assessed per RECIST v1.1 criteria (Cohort 1 and 2) or combined RECIST v1.1 + PCWG3 criteria (Cohort 3). Partial or complete response will require confirmation on repeat scan at least 4 weeks from initial radiologic response
Safety and tolerability in each cancer subtype up to 30 days from treatment discontinuation Adverse events (AEs) will be defined per the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v5.0.
Median Progression- Free Survival (PFS) within each cancer subtype up to 18 months from treatment discontinuation The PFS will be defined as time from date of initial treatment to date of radiological or clinical progression (leading to withdrawal from the study treatment), or death from any cause on study treatment, whichever comes first. Follow-up time will be censored at the date of last disease evaluation.
Duration of Response (DoR) within each cancer subtype up to 18 months from treatment discontinuation DoR will be measured from the start date of the best response achieved until the date of relapse (i.e., progression). Continuing responders will be right-censored as of the most recent date on which their response status had been assessed. DoR applies to only the patients who achieve either a complete response or a partial response.
Trial Locations
- Locations (3)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States