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A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.
Phase 1, PHASE2 trial testing ONCT-534 in Metastatic Castration-resistant Prostate Cancer in 21 participants. Terminated before completion.
| Lead sponsor | Oncternal Therapeutics, Inc |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 20 September 2023 |
| Primary completion | 12 September 2024 |
| Estimated completion | 12 September 2024 |
| Sites | 10 locations across United Kingdom, United States |
Oncternal Therapeutics, Inc — full company profile →
18 and older, male only, with Metastatic Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of DLTs through Study Day 28
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1: 40mg QD | 0 | |
| Dose Level 2: 80mg QD | 0 | |
| Dose Level 3: 160mg QD | 0 | |
| Dose Level 4: 300mg QD | 0 | |
| Dose Level 5: 600mg QD | 0 | |
| Dose Level 6: 1200 mg QD | 0 | |
| BID Dose Level 1: 160 mg BID | 0 | |
| BID Dose Level 2: 300 mg BID | 0 |
Proportion of patients who achieve at least a 50% drop in PSA from baseline (PSA50)
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1: 40mg QD | 0 | |
| Dose Level 2: 80mg QD | 0 | |
| Dose Level 3: 160mg QD | 0 | |
| Dose Level 4: 300mg QD | 0 | |
| Dose Level 5: 600mg QD | 0 | |
| Dose Level 6: 1200 mg QD | 0 | |
| BID Dose Level 1: 160 mg BID | 0 | |
| BID Dose Level 2: 300 mg BID | 0 |
Any reduction in PSA after Baseline (First Day of Treatment)
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1: 40mg QD | 0 | |
| Dose Level 2: 80mg QD | 0 | |
| Dose Level 3: 160mg QD | 2 | |
| Dose Level 4: 300mg QD | 1 | |
| Dose Level 5: 600mg QD | 0 | |
| Dose Level 6: 1200 mg QD | 2 | |
| BID Dose Level 1: 160 mg BID | 0 | |
| BID Dose Level 2: 300 mg BID | 0 |
Time frame: Up to 51 Weeks using the Safety Population. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dose Level 1: 40mg QD | Dose Level 2: 80mg QD | Dose Level 3: 160mg QD | Dose Level 4: 300mg QD | Dose Level 5: 600mg QD | Dose Level 6: 1200 mg QD | BID Dose Level 1: 160 mg BID | BID Dose Level 2: 300 mg BID |
|---|---|---|---|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — |
| Atypical Haemolytic Uraemic Syndrome | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — |
| Lactic Acidosis | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — |
| Non-cardiac Chest Pain | General disorders | — | — | — | — | — | — | — | — |
| Retinal Artery Occlusion | Eye disorders | — | — | — | — | — | — | — | — |
| Seroma | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — |
| Spinal Cord Compression | Nervous system disorders | — | — | — | — | — | — | — | — |
| Urinary Tract Obstruction | Renal and urinary disorders | — | — | — | — | — | — | — | — |
| Urosepsis | Infections and infestations | — | — | — | — | — | — | — | — |
| Reaction | System | Dose Level 1: 40mg QD | Dose Level 2: 80mg QD | Dose Level 3: 160mg QD | Dose Level 4: 300mg QD | Dose Level 5: 600mg QD | Dose Level 6: 1200 mg QD | BID Dose Level 1: 160 mg BID | BID Dose Level 2: 300 mg BID |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — | — | — | — | — |
| Decreased Appetite | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — |
| Oedema Peripheral | General disorders | — | — | — | — | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| Flushing | Vascular disorders | — | — | — | — | — | — | — | — |
| Hot Flush | Vascular disorders | — | — | — | — | — | — | — | — |
| Lumbroscral Plexopathy | Nervous system disorders | — | — | — | — | — | — | — | — |
| Paresthesia | Nervous system disorders | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| Blood Alkaline Phosphatase Increased | Investigations | — | — | — | — | — | — | — | — |
| Gastrointestinal Disorder | Gastrointestinal disorders | — | — | — | — | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — | — | — | — | — |
| Urinary Retention | Renal and urinary disorders | — | — | — | — | — | — | — | — |
| Urinary Tract Infection | Infections and infestations | — | — | — | — | — | — | — | — |
| Blood Creatinine Increase | Investigations | — | — | — | — | — | — | — | — |
| Extradural Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — | — | — |
| International Normalised Ratio Increased | Investigations | — | — | — | — | — | — | — | — |
| Spinal Cord Compression | Nervous system disorders | — | — | — | — | — | — | — | — |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — | — | — | — | — | — |
| Blood Lactate Dehydrogenase Increased | Investigations | — | — | — | — | — | — | — | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| Pelvic Pain | Reproductive system and breast disorders | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — | — | — | — | — |
| Atrioventricular Block First Degree | Cardiac disorders | — | — | — | — | — | — | — | — |
| Blood Bilirubin Increased | Investigations | — | — | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — |
| Platelet Count Decreased | Investigations | — | — | — | — | — | — | — | — |
| Proteinuria | Renal and urinary disorders | — | — | — | — | — | — | — | — |
| Urinary Incontinence | Renal and urinary disorders | — | — | — | — | — | — | — | — |
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — |
| Blood Creatinine Phophokinase Increased | Investigations | — | — | — | — | — | — | — | — |
| Bone Pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Back Pain, Acute Kidney Injury, Anaemia, Atypical Haemolytic Uraemic Syndrome, Lactic Acidosis, Non-cardiac Chest Pain, Retinal Artery Occlusion, Seroma.
Data from ClinicalTrials.gov NCT05917470 adverse events section.
A first-in-human clinical trial to test the investigational treatment ONCT-534 in participants with metastatic castration-resistant prostate cancer. The main questions it aims to answer are: * What are the most tolerable doses of ONCT-534? (Phase 1) * Does ONCT-534 have anti-tumor activity at tolerable doses? (Phase 2) This is a dose escalation and expansion study where participants will receive daily oral doses of ONCT-534.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05917470.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing