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Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency
Phase 2 trial testing Pamiparib in Metastatic Castration-Resistant Prostate Cancer (mCRPC) in 13 participants. Terminated before completion.
| Lead sponsor | BeiGene |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 5 February 2019 |
| Primary completion | 6 August 2020 |
| Estimated completion | 2 September 2020 |
| Sites | 9 locations across Puerto Rico, United States, Australia, Spain |
BeiGene — full company profile →
18 and older, male only, with Metastatic Castration-Resistant Prostate Cancer (mCRPC) or Homologous Recombination Deficiency (HRD). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by an Independent Review Committee (IRC).
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | 0 |
PSA response rate is defined as the percentage of participants with PSA decline ≥ 50% from baseline \[confirmed by a second PSA value ≥ 3 weeks later\] for CTC-HRD-positive participants with or without measurable disease.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | 0 |
DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to radiographic disease progression or death due to any cause, whichever occurs first.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | NA |
ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by the investigator.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | 0 |
Time to objective response is defined as the time from the date of the first dose of study drug to the first documented confirmed response of CR or PR assessed by the investigator and summarized for participants who have achieved a confirmed objective response.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | NA |
Clinical Benefit Rate is the percentage of participants who achieved confirmed CR, PR, or SD or NON-CR/NON-PD. The minimum interval for confirmed CR and PR is 4 weeks and the measurement of SD or NON-CR/NON-PD is 7 weeks after first dose date.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | 25 |
Time to PSA response is defined as the time from the date of the first dose of study drug to the first PSA decline ≥ 50% that is subsequently confirmed. Assessments are summarized for participants who have achieved a confirmed PSA response.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | NA |
Duration of PSA response is defined as the time from the date of the earliest documented PSA response (that is subsequently confirmed) to PSA progression or death due to any cause, whichever occurs first. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 μg/L above the nadir (or above the baseline for participants with no PSA decline) after12 weeks, confirmed by a second value ≥ 3 weeks later. The nadir is defined as the lowest value at or after baseline.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | NA |
Time to PSA progression is defined as the time from the date of the first dose of study drug to a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline for participants with no PSA decline) after 12 weeks, confirmed by a second value ≥ 3 weeks later. Death for the participants with no PSA progression is also considered as an event.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | 3.13 | ± 1.533 |
Time to symptomatic skeletal event (SSE) is defined as time from the date of the first dose of study drug to the first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | NA |
Radiographic progression-free survival is defined as the time from the date of the first dose of study drug to radiographic disease progression by IRC or death due to any cause, whichever occurs first.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | 2.6 | 1.5 – 3.7 |
Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause.
| Group | Value | 95% CI |
|---|---|---|
| Pamiparib | 5.8 | 1.6 – 5.9 |
Time frame: From the date of first dose of Pamiparib until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first (up to approximately 1 year and 7 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pamiparib |
|---|---|---|
| Pyrexia | General disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Hemiparesis | Nervous system disorders | — |
| Hydronephrosis | Renal and urinary disorders | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Oesophageal candidiasis | Infections and infestations | — |
| Pancytopenia | Blood and lymphatic system disorders | — |
| Peripheral swelling | General disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Ureteric obstruction | Renal and urinary disorders | — |
| Reaction | System | Pamiparib |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Weight decreased | Investigations | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Blood creatinine increased | Investigations | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Asthenia | General disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Blood lactate dehydrogenase increased | Investigations | — |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Constipation | Gastrointestinal disorders | — |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Dry eye | Eye disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Haematuria | Renal and urinary disorders | — |
| Headache | Nervous system disorders | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Malnutrition | Metabolism and nutrition disorders | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Oral candidiasis | Infections and infestations | — |
| Orbital oedema | Eye disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Pyrexia, Anemia, Back pain, Dehydration, Febrile neutropenia, Hemiparesis, Hydronephrosis, Musculoskeletal chest pain.
Data from ClinicalTrials.gov NCT03712930 adverse events section.
This study is designed to evaluate the efficacy of pamiparib in participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). All participants will receive pamiparib. The purpose of this study is to demonstrate that pamiparib will improve Objective Response Rate (ORR) and Prostate-Specific Antigen (PSA) response rate
8 peer-reviewed publications reference this trial (live from Europe PMC):
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