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ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer
Phase 2 trial testing ESK981 in Castration Levels of Testosterone in 13 participants. Completed in 9 May 2023.
| Lead sponsor | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 8 March 2018 |
| Primary completion | 15 March 2023 |
| Estimated completion | 9 May 2023 |
| Sites | 2 locations across United States |
Barbara Ann Karmanos Cancer Institute
18 and older, male only, with Castration Levels of Testosterone or Castration-Resistant Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PSA decline of \>= 50% (PSA50) from baseline using Prostate Cancer Working Group 3 (PCWG3) definition with point estimate and (1-sided Wilson type 90% lower) confidence interval (CI) estimates.
| Group | Value | 95% CI |
|---|---|---|
| Treatment ESK981 | 7.7 | 1.7 – 28.2 |
Will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for RD will be generated along with the Hall-Wellner 90% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (6-month rate, 12-month rate, median, etc.) will be calculated from the K-M life table, each one with its respective 80% CI.
| Group | Value | 95% CI |
|---|---|---|
| Treatment ESK981 | 1.9 |
Will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for PFS will be generated along with the Hall-Wellner 90% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (6-month rate, 12-month rate, median, etc.) will be calculated from the K-M life table, each one with its respective 80% CI.
| Group | Value | 95% CI |
|---|---|---|
| Treatment ESK981 | 0.9 | 0.2 – 1.9 |
Will be used to summarize the time to PSA response. These descriptives will include sample size (N), median, mean, standard deviation (SD), interquartile range (IQR), minimum, and maximum.
| Group | Value | 95% CI |
|---|---|---|
| Treatment ESK981 | 10.0 |
Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment ESK981 |
|---|---|---|
| Cardiac disorders - Other, specify | Cardiac disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypertension | Vascular disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Myocardial infarction | Cardiac disorders | — |
| Skin infection | Infections and infestations | — |
| Reaction | System | Treatment ESK981 |
|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Fatigue | General disorders | — |
| Pain | General disorders | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Localized edema | General disorders | — |
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Vascular disorders - Other, specify | Vascular disorders | — |
| Weight loss | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Anxiety | Psychiatric disorders | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Cardiac disorders - Other, specify | Cardiac disorders | — |
| Chills | General disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Eye disorders - Other, specify | Eye disorders | — |
| General disorders and administration site condi | General disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
| Insomnia | Psychiatric disorders | — |
| Lymphedema | Vascular disorders | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Pelvic pain | Reproductive system and breast disorders | — |
| Reproductive system and breast disorders - Othe | Reproductive system and breast disorders | — |
| Sinusitis | Infections and infestations | — |
| Urinary frequency | Renal and urinary disorders | — |
| Vomiting | Gastrointestinal disorders | — |
Most-reported serious reactions: Cardiac disorders - Other, specify, Alanine aminotransferase increased, Aspartate aminotransferase increased, Dehydration, Diarrhea, Hyperglycemia, Hypertension, Hyponatremia.
Data from ClinicalTrials.gov NCT03456804 adverse events section.
This phase II trials studies the side effects and how well ESK981 works in treating patients with castration-resistant prostate cancer that has spread to other places in the body. ESK981 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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