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Androgen Deprivation Therapy

Talazoparib + ADT + Abiraterone for Prostate Cancer

Phase 2

Recruiting

Led By Tanya B Dorff

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

All patients must have metastatic disease: either soft tissue and/or bony metastases prior to initiation of androgen. Measurable disease is not required

Calculated creatinine clearance >= 30 mL/min using a serum creatinine obtained within 28 days prior to registration

Must not have

Patients with a known history of primary and secondary adrenal insufficiency are not eligible

Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Approved for 50 Other Conditions

No Placebo-Only Group

Summary

This trial is studying the effect of talazoparib with androgen deprivation therapy and abiraterone in treating patients with castration sensitive prostate cancer.

Who is the study for?

This trial is for men with castration sensitive prostate cancer that has spread, and who have not had certain treatments. They must be able to perform daily activities without significant assistance (Karnofsky performance status of 60-100). Participants need normal liver function tests, a creatinine clearance >=30 mL/min, and agree to use contraception or abstain from intercourse during the study.

What is being tested?

The trial is testing talazoparib combined with androgen deprivation therapy (ADT) and abiraterone. Talazoparib blocks an enzyme called PARP which helps repair DNA in tumor cells; ADT lowers body's production of androgens that can promote tumor growth; abiraterone works alongside ADT to further reduce androgen levels.

What are the potential side effects?

Potential side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, heart issues like high blood pressure or heart failure symptoms worsening if pre-existing conditions are present. Allergic reactions could occur based on individual sensitivities.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread to other parts of my body, including bones or soft tissues.

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My kidney function, measured by creatinine clearance, is adequate.

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I am willing to stop taking bicalutamide if I join the trial.

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I can care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a history of adrenal insufficiency.

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I have not had chemotherapy for metastatic prostate cancer.

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I do not have any stomach or intestine problems that affect how I absorb medicine.

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I do not have HIV, chronic hepatitis B or C, or any severe illness that could affect my study participation.

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I don't have severe heart failure or recent serious heart problems.

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I am allergic to drugs similar to those used in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prostate specific antigen (PSA) nadir < 0.2

Secondary study objectives

Androgen receptor (AR) genetic variations

Objective response rate

PSA responses

+2 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777

100%

Fatigue

100%

Headache

67%

Platelet count decreased

67%

Hyperglycemia

67%

Anemia

67%

Back pain

33%

Lymphocyte count decreased

33%

Fever

33%

Nervous system disorders - Other, PARALYSIS

33%

Pain in extremity

33%

Weight loss

33%

Hyponatremia

33%

Hypoglycemia

33%

Neutrophil count decreased

33%

White blood cell decreased

33%

Skin infection

33%

Hypokalemia

33%

Peripheral motor neuropathy

33%

Insomnia

33%

Sinus tachycardia

33%

Creatinine increased

33%

Alanine aminotransferase increased

33%

Peripheral sensory neuropathy

33%

Diarrhea

33%

Hypermagnesemia

33%

Constipation

33%

Hypophosphatemia

33%

Gastroesophageal reflux disease

33%

Skin ulceration

33%

Muscle weakness lower limb

33%

Cough

33%

Non-cardiac chest pain

33%

Scoliosis

33%

Urinary incontinence

33%

Nystagmus

33%

Arthralgia

33%

Gait disturbance

33%

Edema limbs

33%

Hypertension

33%

Chills

33%

Investigations - Other, AST DECREASED

33%

Nervous system disorders - Other, HYPOTONIC

33%

Alopecia

33%

Aspartate aminotransferase increased

33%

Blurred vision

33%

Investigations - Other, ALT DECREASED

33%

Hypothyroidism

33%

Nausea

33%

Investigations - Other, BUN DECREASED

33%

Alkaline phosphatase increased

33%

Neuralgia

33%

Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA

33%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/doseBMN 673 BID+55mg/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 BID+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day

Awards & Highlights

Approved for 50 Other Conditions

This treatment demonstrated efficacy for 50 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (talazoparib, androgen deprivation therapy)Experimental Treatment8 Interventions

Patients receive talazoparib PO QD, abiraterone acetate PO QD, and prednisone PO QD on days 1-28. Patients also receive androgen deprivation therapy consisting of degarelix SC on day 1; leuprolide acetate IM on day 1 and bicalutamide PO QD on days 1-28 of cycle 1 and then leuprolide acetate IM on day 1 of subsequent cycles; leuprolide acetate IM on day 1 and bicalutamide PO QD on days 1-28 of cycle 1 and then leuprolide acetate IM on day 1 of cycles 2, 5, 8, and 11; or goserelin acetate SC monthly or every 3 months. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylprednisolone

FDA approved

Abiraterone

FDA approved

Bicalutamide

FDA approved

Degarelix

FDA approved