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ESK981 for Cancer

Phase 2
Recruiting
Led By Vaibhav Sahai
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histological or cytological confirmation of advanced cancer per specific cohort
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
Must not have
No prior malignancy except for specific exceptions
Must not have uncontrolled hypertension defined as blood pressure >150/90 despite optimal medical management
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months from treatment discontinuation
Awards & highlights
No Placebo-Only Group

Summary

This trial will include patients with different types of cancers - pancreatic adenocarcinoma, adenosquamous carcinoma, gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67

Who is the study for?
This trial is for adults with certain advanced cancers, including pancreatic adenocarcinoma, gastrointestinal/pancreatic neuroendocrine tumors with high Ki-67 levels, and neuroendocrine prostate carcinoma. Participants must have progressed beyond or be intolerant to standard treatments and meet specific criteria like having visceral metastases or a high volume of disease.
What is being tested?
The study tests ESK981 in patients across three cohorts based on their cancer type. Patients take the drug orally for five days followed by a two-day break, repeating this cycle every four weeks while keeping track of their medication intake in a diary.
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions to cancer medications such as nausea, fatigue, digestive issues, potential blood count changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer type has been confirmed by lab tests.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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I agree not to donate sperm during and for 6 months after treatment.
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I can undergo CT or MRI scans with contrast without issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had cancer before, except for certain types.
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My blood pressure is controlled and below 150/90.
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I have had a condition where my lymphocytes grow abnormally.
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I have a history of cancer.
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I am not on daily medication that strongly affects certain enzymes.
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I do not have ongoing severe diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months from treatment discontinuation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months from treatment discontinuation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival
Secondary study objectives
Duration of Response (DoR) within each cancer subtype
Median Progression- Free Survival (PFS) within each cancer subtype
Overall Response Rate (ORR) within each cancer subtype
+2 more

Side effects data

From 2023 Phase 2 trial • 13 Patients • NCT03456804
31%
Back pain
31%
Pain
31%
Fatigue
23%
Gastrointestinal disorders - Other, specify
15%
Vascular disorders - Other, specify
15%
Diarrhea
15%
Weight loss
15%
Musculoskeletal and connective tissue disorder
15%
Pain in extremity
15%
Localized edema
15%
Cardiac disorders - Other, specify
15%
Constipation
15%
Hypertension
8%
Nervous system disorders - Other, specify
8%
Bruising
8%
Chills
8%
Reproductive system and breast disorders - Othe
8%
General disorders and administration site condi
8%
Alanine aminotransferase increased
8%
Pelvic pain
8%
Hypotension
8%
Nausea
8%
Sinusitis
8%
Urinary frequency
8%
Vomiting
8%
Hoarseness
8%
Lymphedema
8%
Skin infection
8%
Muscle weakness lower limb
8%
Myocardial infarction
8%
Eye disorders - Other, specify
8%
Hematuria
8%
Non-cardiac chest pain
8%
Aspartate aminotransferase increased
8%
Hyperglycemia
8%
Lymphocyte count decreased
8%
Dehydration
8%
Anorexia
8%
Dizziness
8%
Generalized muscle weakness
8%
Insomnia
8%
Headache
8%
Hyponatremia
8%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment ESK981

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Neuroendocrine prostate carcinoma with Ki-67 \> 20%
Group II: Cohort 2Experimental Treatment1 Intervention
Pancreatic or gastrointestinal neuroendocrine neoplasms with Ki-67 \> 20%
Group III: Cohort 1Experimental Treatment1 Intervention
Pancreatic adenocarcinoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ESK981
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,299 Total Patients Enrolled
Vaibhav SahaiPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
~44 spots leftby Apr 2027
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