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An Open-label Study of the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer
Phase 2 trial testing eFT508 in Castrate-resistant Prostate Cancer (CRPC) in 16 participants. Terminated before completion.
| Lead sponsor | Effector Therapeutics |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 27 November 2018 |
| Primary completion | 27 April 2020 |
| Estimated completion | 27 April 2020 |
| Sites | 10 locations across United States |
Effector Therapeutics — full company profile →
18 and older, male only, with Castrate-resistant Prostate Cancer (CRPC). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
* A ≥50% PSA decline from baseline at any time point after therapy and maintained for ≥4 weeks * Objective response according to iRECIST 1.1
| Group | Value | 95% CI |
|---|---|---|
| Tomivosertib (eFT508) 200 mg Twice Daily | 0 |
PSA progression is defined as a ≥25% increase in PSA from nadir or baseline (and by ≥2 ng/mL) and requires confirmation ≥3 weeks later.
| Group | Value | 95% CI |
|---|---|---|
| Tomivosertib (eFT508) | 8.1 | 4.1 – 31.1 |
Time frame: Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tomivosertib (eFT508) 200 … |
|---|---|---|
| Chest Pain | General disorders | — |
| Death | General disorders | — |
| Disease progression | General disorders | — |
| Bronchitis | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Urosepsis | Infections and infestations | — |
| Haematuria | Renal and urinary disorders | — |
| Obstructive Nephropathy | Renal and urinary disorders | — |
| Urinary bladder rupture | Renal and urinary disorders | — |
| Diverticulum | Gastrointestinal disorders | — |
| Urinary tract stoma complication | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Seizure | Nervous system disorders | — |
| Reaction | System | Tomivosertib (eFT508) 200 … |
|---|---|---|
| nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Tremor | Nervous system disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hypercalcemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Rectal haemorrhage | Gastrointestinal disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Edema peripheral | General disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Blood creatine phosphokinase increased | Investigations | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Diverticulum | Gastrointestinal disorders | — |
| Gastritis | Gastrointestinal disorders | — |
| Oesophagitis | Gastrointestinal disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Iron deficiency | Metabolism and nutrition disorders | — |
| Chest pain | General disorders | — |
| Death | General disorders | — |
| Disease progression | General disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Pain | General disorders | — |
| Ataxia | Nervous system disorders | — |
| Balance disorder | Nervous system disorders | — |
| Dysarthria | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Poor quality sleep | Nervous system disorders | — |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | — |
| Seizure | Nervous system disorders | — |
Most-reported serious reactions: Chest Pain, Death, Disease progression, Bronchitis, Pneumonia, Urosepsis, Haematuria, Obstructive Nephropathy.
Data from ClinicalTrials.gov NCT03690141 adverse events section.
This Phase 2 Open-label Study examines the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib (eFT508) in Patients with advanced CRPC. An Open-label Study Examining the Effect of tomivosertib (eFT508) in Patients with Advanced Castrate-resistant Prostate Cancer (CRPC)
8 peer-reviewed publications reference this trial (live from Europe PMC):
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