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PARP Inhibitor

Talazoparib for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during study treatment (approximately up to 36 months)
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during study treatment (approximately up to 36 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during study treatment (approximately up to 36 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Objective Response Rate (ORR)
Secondary outcome measures
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS)
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3
Duration of Response (DOR)
+22 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
89%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Constipation
44%
Hypoalbuminemia
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Cough
22%
Hypokalemia
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Bone pain
11%
Allergic reaction
11%
Weight loss
11%
Tumor pain
11%
Febrile neutropenia
11%
Periorbital infection
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

Trial Design

1Treatment groups
Experimental Treatment
Group I: TalazoparibExperimental Treatment1 Intervention
Talazoparib 1 mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770

Find a Location

Who is running the clinical trial?

Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,114 Total Patients Enrolled
11 Trials studying Prostate Cancer
540 Patients Enrolled for Prostate Cancer
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,907,922 Total Patients Enrolled
41 Trials studying Prostate Cancer
12,241 Patients Enrolled for Prostate Cancer
Pfizer Pfizer CT.gov Call CenterStudy DirectorPfizer
22 Previous Clinical Trials
6,479 Total Patients Enrolled
5 Trials studying Prostate Cancer
3,028 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Talazoparib been cleared by the FDA for public consumption?

"While there is some evidence to support Talazoparib's safety, it did not receive a higher score due Phase 2 trials only provide data on safety and none on efficacy."

Answered by AI

How many individuals are taking part in this experiment?

"Presently, this clinical study is not enrolling patients. Although, it was accepting participants between July 4th 2017 and October 26th 2022. If you are interested in other research trials, there are 1367 active prostate cancer studies and 60 for Talazoparib currently looking for willing individuals."

Answered by AI

Are recruitment efforts for this clinical trial still underway?

"Although no longer enrolling patients, this study was most recently active on October 26th, 2022. It was first posted to clinicaltrials.gov on July 4th, 2017. There are currently 1427 other trials that are still recruiting participants."

Answered by AI

What is the primary goal of this research?

"The primary outcome of this clinical trial is the best objective response rate (ORR), which will be evaluated over a 34-month period. Secondary outcomes include the number of participants with a shift in laboratory parameter values from grade 2 or below at baseline to grade 3 or 4 post-baseline, the proportion of patients with conversion of circulating tumor cell (CTC) count, and the time to objective response."

Answered by AI

What does the existing research say about Talazoparib's efficacy?

"City of Hope first researched talazoparib in 2010 and since then, there have been 23 completed clinical trials. As of now, 60 different medical studies are still ongoing with many taking place in Albemarle, South carolina."

Answered by AI

Are there different research hospitals conducting this trial across North America?

"This study has 42 enrolled patients at sites such as the Levine Cancer Institute-Albermarle in Albemarle, Parkway Surgery Center in Myrtle Beach, and Medical Oncology Associates-SD in San Diego."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
2017. "A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03148795.
~17 spots leftby Apr 2025
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