Talazoparib for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate CancerTalazoparib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing the effectiveness and safety of talazoparib in men with metastatic prostate cancer who have a DNA repair defect and have progressed on taxane-based chemotherapy and at least one novel hormonal agent.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 31 Secondary · Reporting Duration: Approximately 56 months

Week 1
Post-dose Plasma Concentration (Ctrough) of Talazoparib
Month 34
Duration of response
Objective Response Rate (ORR)
Overall survival
Patient-reported health-related quality of life as assessed by the European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L)
Pain
Pharmacokinetics (PK) of talazoparib as assessed by trough plasma concentrations
Circulating Neoplastic Cells
Complement H50
Radiographic progression-free survival (PFS)
Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug
Time to PSA progression
Time to objective response
Approximately 56 months
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Till End of the Study
Change From Baseline in Patient-Reported Health-Related Quality of Life as Assessed by European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Scores Till End of the Study
Overall Survival (OS)
Percentage of Participants With Circulating Tumor Cell (CTC) Count <5 CTC Per 7.5 mL of Blood at Baseline Increased Any Time on Study
Percentage of Participants With Circulating Tumor Cell (CTC) Count >=1 CTC Per 7.5 mL of Blood at Baseline Decreasing to Null CTC of Blood Any Time on Study
Percentage of Participants With Circulating Tumor Cell (CTC) Count Greater Than or Equal to (>=) 5 Circulating Tumor Cell (CTC) Per 7.5 Milliliter (mL) of Blood at Baseline Decreasing to Less Than (<) 5 CTC of Blood Any Time on Study
Percentage of Participants With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percent (%)
Time to Deterioration in Pain Symptom Scores
Time to Prostate-Specific Antigen (PSA) Progression
Month 26
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Number of Participants With Dose Modification
Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Month 25
Radiographic Progression-Free Survival (PFS)
Month 25
Best Objective Response Rate (ORR)
Month 25
Time to Objective Response
Month 25
Duration of Response (DOR)
Week 1
Pre-dose Plasma Concentration (Ctrough) of Talazoparib

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
89%Anemia
78%Alkaline phosphatase increased
78%Nausea
78%White blood cell decreased
67%Fatigue
67%Lymphocyte count decreased
56%Headache
56%Hypermagnesemia
56%Pain in extremity
56%Platelet count decreased
56%Neutrophil count decreased
56%Aspartate aminotransferase increased
44%Constipation
44%Hyponatremia
44%Hypoalbuminemia
44%Non-cardiac chest pain
33%Alanine aminotransferase increased
33%Blood bilirubin increased
33%Fever
33%Alopecia
33%Back pain
33%Anorexia
33%Dizziness
33%Diarrhea
33%Proteinuria
33%Hyperglycemia
33%Hypocalcemia
33%Pain
33%Sinus tachycardia
33%Vomiting
33%Creatinine increased
22%Hypercalcemia
22%Hypoxia
22%Nasal congestion
22%Dyspnea
22%Hypernatremia
22%Neck pain
22%Abdominal pain
22%Cough
22%Hypokalemia
22%Hypophosphatemia
22%Hypotension
11%Gastroesophageal reflux disease
11%Hematuria
11%Avascular necrosis
11%Hypomagnesemia
11%Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%Tumor pain
11%Activated partial thromboplastin time prolonged
11%Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%Depression
11%Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%Hemoglobin increased
11%Hypertension
11%Investigations - Other, BICARBONATE DECREASED
11%Mucosal infection
11%Rash acneiform
11%Skin ulceration
11%Tinnitus
11%Gait disturbance
11%Edema face
11%Lymphocyte count increased
11%Irregular menstruation
11%Investigations - Other, BICARBONATE LOW
11%Allergic reaction
11%Bone pain
11%Cystitis noninfective
11%Edema limbs
11%Epistaxis
11%Infections and infestations - Other, SHINGLES ZOSTER
11%Insomnia
11%Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%Muscle weakness right-sided
11%Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%Febrile neutropenia
11%Pericardial effusion
11%Pleural effusion
11%Renal and urinary disorders - Other, BLADDER PAIN
11%Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%Skin hyperpigmentation
11%Stomach pain
11%Thromboembolic event
11%Dysgeusia
11%Urinary retention
11%Urinary urgency
11%Weight loss
11%Periorbital infection
11%Anxiety
11%Investigations - Other, BICARBONATE INCREASED
11%Obesity
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT02116777) in the 600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day ARM group. Side effects include: Anemia with 89%, Alkaline phosphatase increased with 78%, Nausea with 78%, White blood cell decreased with 78%, Fatigue with 67%.

Trial Design

1 Treatment Group

Talazoparib
1 of 1

Experimental Treatment

128 Total Participants · 1 Treatment Group

Primary Treatment: Talazoparib · No Placebo Group · Phase 2

Talazoparib
Drug
Experimental Group · 1 Intervention: Talazoparib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 56 months

Who is running the clinical trial?

PfizerLead Sponsor
4,308 Previous Clinical Trials
7,110,707 Total Patients Enrolled
37 Trials studying Prostate Cancer
10,247 Patients Enrolled for Prostate Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,114 Total Patients Enrolled
12 Trials studying Prostate Cancer
607 Patients Enrolled for Prostate Cancer
Pfizer Pfizer CT.gov Call CenterStudy DirectorPfizer
20 Previous Clinical Trials
6,156 Total Patients Enrolled
5 Trials studying Prostate Cancer
3,028 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

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References