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PARP Inhibitor

Talazoparib + Temozolomide for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Karen Autio, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed adenocarcinoma of the prostate

ECOG status of 0 or 1 (Appendix A: Performance Status Criteria)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after last dose of study treatment (+/- 3 days)

Awards & highlights

Study Summary

This trial will test the safety of talazoparib plus temozolomide in men with mCRPC.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to castration and has progressed after hormone therapy can join. They need a PSA increase, metastatic disease confirmed by scans, and good organ function. No recent radiation or certain drugs, no genetic mutations in specific DNA repair genes, and no other cancers within the last two years.Check my eligibility

What is being tested?

The trial is testing Talazoparib combined with Temozolomide for safety at the highest dose without severe side effects (1mg Talazoparib & 75mg/m² Temozolomide). Phase II checks how well this combo works against advanced prostate cancer that doesn't respond to hormone therapy.See study design

What are the potential side effects?

Talazoparib may cause blood cell count changes, nausea, fatigue, loss of appetite; while Temozolomide might lead to headaches, constipation or diarrhea, vomiting. Both drugs could potentially lower immunity making infections more likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer was confirmed by a lab test.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am a man aged 18 or older.

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I have undergone bilateral orchiectomy or am on hormone therapy for cancer.

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My prostate cancer has worsened despite treatment with specific hormone therapies.

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My bone disease has worsened or I have two or more new bone lesions.

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My cancer has spread and this was confirmed by a bone scan or CT/MRI.

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I agree to a new tumor biopsy or have enough stored tumor tissue for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after last dose of study treatment (+/- 3 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after last dose of study treatment (+/- 3 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after last dose of study treatment (+/- 3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Phase II: Overall Response Rate

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%

Hypokalemia

22%

Cough

22%

Abdominal pain

22%

Dyspnea

22%

Hypercalcemia

22%

Hypernatremia

22%

Hypophosphatemia

22%

Hypotension

22%

Hypoxia

22%

Nasal congestion

22%

Neck pain

11%

Weight loss

11%

Periorbital infection

11%

Bone pain

11%

Allergic reaction

11%

Tumor pain

11%

Febrile neutropenia

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%

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: Metastatic Castration Resistant Prostate CancerExperimental Treatment2 Interventions

Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1930

Talazoparib

2021

Completed Phase 2

~2770

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,882 Total Patients Enrolled

132 Trials studying Prostate Cancer

52,030 Patients Enrolled for Prostate Cancer

Karen Autio, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

16 Total Patients Enrolled

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04019327 — Phase 1 & 2

Prostate Cancer Research Study Groups: Metastatic Castration Resistant Prostate Cancer

Prostate Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT04019327 — Phase 1 & 2

Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04019327 — Phase 1 & 2

Frequently Asked Questions

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

What applications has Talazoparib been found to be efficacious in?

"Talazoparib is the recommended course of action for nitrosourea treatment and has also proven to be beneficial in treating refractory neuroblastoma, advanced mycosis fungoides, and other forms of advance directives."

Answered by AI

Have any comparable studies been conducted utilizing Talazoparib?

"Currently, Talazoparib has over two hundred and sixty-one active studies in progress with twenty-seven taking place during the third phase. Though many of these trials take place from Seoul's Songpa district, there are seven thousand and fifty six sites around the world participating in research concerning this drug."

Answered by AI

How extensively is this clinical trial being implemented across hospitals?

"Patients can seek out the trial at 8 different locations, including Memorial Sloan Kettering Westchester (Limited Protocol Activities) in Harrison and Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale. Additionally, there are 6 other centres hosting this study."

Answered by AI

What is the upper limit for participants of this clinical trial?

"This research requires 55 participants who satisfy the given inclusion criteria. Potential candidates can participate in this study from locations such as Memoral Sloan Kettering Westchester (Limited Protocol Activities) in Harrison, Wisconsin and Memorial Sloan Kettering Cancer Center in New york, Virginia."

Answered by AI

Are there currently openings available for participants within this examination?

"According to clinicaltrials.gov, this investigation is actively seeking participants and was first published on July 11th 2019, with the most recent revision being made on August 8th 2022."

Answered by AI

Does this clinical experiment represent a pioneering attempt in the field?

"To date, 261 clinical trials involving talazoparib are being conducted across 1280 distinct cities in 45 countries. It all began with a Phase 2 trial held by Schering-Plough back in 2002 that was completed by 60 patients; since then, 316 additional studies have been brought to completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

2019. "A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04019327.

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