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M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Phase 2 trial testing Berzosertib in Castration-Resistant Prostate Carcinoma in 73 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 29 May 2019 |
| Primary completion | 10 August 2021 |
| Estimated completion | 3 April 2026 |
| Sites | 23 locations across United States |
National Cancer Institute (NCI)
18 and older, male only, with Castration-Resistant Prostate Carcinoma or Metastatic 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.
Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen \[PSA\] response (\> 50% decline from baseline).
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Docetaxel, Carboplatin) | 5 | |
| Arm B (Carboplatin, Berzosertib) | 0 |
Assessed by Prostate Cancer Working Group (PCWG) 3 criteria. PFS to be estimated with the Kaplan Meier methodology. Median will be provided with 95% confidence interval.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Docetaxel, Carboplatin) | 2.5 | 2.1 – 4.2 |
| Arm B (Carboplatin, Berzosertib) | 2.4 | 2.1 – 3.5 |
Assessed by PCWG2. PSA progression will be estimated with the Kaplan Meier methodology. Median will be provided with 95% confidence interval.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Docetaxel, Carboplatin) | 2.1 | 1.4 – 3.6 |
| Arm B (Carboplatin, Berzosertib) | 1.4 | 1.0 – 2.8 |
Assessed by RECIST 1.1 for non-osseous disease and by PCWG3 for osseous disease. rPFS will be estimated with the Kaplan Meier methodology. Median will be provided with 95% confidence interval.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Docetaxel, Carboplatin) | 3.2 | 2.1 – 5.1 |
| Arm B (Carboplatin, Berzosertib) | 2.6 | 2.1 – 4.8 |
Adverse events will be graded and analyzed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Docetaxel, Carboplatin) | 34 | |
| Arm B (Carboplatin, Berzosertib) | 31 |
OS will be estimated with the Kaplan Meier methodology.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Docetaxel, Carboplatin) | 8.4 | 4.5 – 12.8 |
| Arm B (Carboplatin, Berzosertib) | 5.7 | 4.6 – 8.1 |
The frequency of homologous recombination (HR) deficiency detected from baseline tumor biopsy is summarized by arm at baseline.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Docetaxel, Carboplatin) | 3 | |
| Arm B (Carboplatin, Berzosertib) | 3 |
Time frame: From treatment initiation to 30 days after the last dose of study treatment, up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Docetaxel, Carbopla… | Arm B (Carboplatin, Berzos… |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Fever | General disorders | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Pain | General disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Platelet Count Decreased | Investigations | — | — |
| Bone Pain | Musculoskeletal and connective tissue disorders | — | — |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | — | — |
| Demand Ischemia | Cardiac disorders | — | — |
| Myocardial Infarction | Cardiac disorders | — | — |
| Sinus Tachycardia | Cardiac disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Rectal Obstruction | Gastrointestinal disorders | — | — |
| Rectal Pain | Gastrointestinal disorders | — | — |
| Death Nos | General disorders | — | — |
| Edema Limbs | General disorders | — | — |
| Gait Disturbance | General disorders | — | — |
| Malaise | General disorders | — | — |
| Abdominal Infection | Infections and infestations | — | — |
| Enterocolitis Infectious | Infections and infestations | — | — |
| Lung Infection | Infections and infestations | — | — |
| Tooth Infection | Infections and infestations | — | — |
| Urinary Tract Infection | Infections and infestations | — | — |
| Reaction | System | Arm A (Docetaxel, Carbopla… | Arm B (Carboplatin, Berzos… |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Platelet Count Decreased | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| White Blood Cell Decreased | Investigations | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Aspartate Aminotransferase Increased | Investigations | — | — |
| Fever | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Neutrophil Count Decreased | Investigations | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Lymphocyte Count Decreased | Investigations | — | — |
| Weight Loss | Investigations | — | — |
| Creatinine Increased | Investigations | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | — | — |
| Alkaline Phosphatase Increased | Investigations | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Edema Limbs | General disorders | — | — |
| Alanine Aminotransferase Increased | Investigations | — | — |
| Blood Lactate Dehydrogenase Increased | Investigations | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Bone Pain | Musculoskeletal and connective tissue disorders | — | — |
| Peripheral Sensory Neuropathy | Nervous system disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Sinus Tachycardia | Cardiac disorders | — | — |
| Pain | General disorders | — | — |
| Urinary Tract Infection | Infections and infestations | — | — |
Most-reported serious reactions: Anemia, Fever, Abdominal Pain, Fatigue, Pain, Sepsis, Platelet Count Decreased, Bone Pain.
Data from ClinicalTrials.gov NCT03517969 adverse events section.
This phase II trial studies how well berzosertib (M6620) and carboplatin with or without docetaxel works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving M6620, carboplatin and docetaxel may work better in treating patients with metastatic castration-resistant prostate cancer compared to carboplatin and docetaxel alone.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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