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PARP Inhibitor

Talazoparib for Leukemia

Phase 1

Recruiting

Led By Jacqueline Garcia, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Persistent MDS/AML disease despite receiving at least 2 cycles of hypomethylating agent and venetoclax

Age 18 years and older.

Must not have

Participants with known CNS leukemia.

Pregnant women are excluded from this study because Talazoparib is a PARP inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Talazoparib, breastfeeding should be discontinued if the mother is treated with Talazoparib. These potential risks may also apply to other agents used in this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Talazoparib is an effective treatment for patients with AML or MDS that have a mutation in the cohesin complex.

Who is the study for?

Adults with AML or MDS and a cohesin complex mutation who can't have intensive chemotherapy. They should have at least 5% blasts in blood/marrow, be ineligible for approved AML therapies, and not received leukemia treatment within 2 weeks before the trial. Participants need normal organ function, agree to contraception, and not be pregnant.

What is being tested?

The study is examining Talazoparib's effectiveness on patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) that carry specific genetic mutations. It will see if this drug can help where standard treatments aren't suitable.

What are the potential side effects?

Talazoparib may cause side effects like nausea, fatigue, anemia, low blood cell counts leading to increased infection risk or bleeding problems. The severity of these side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

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

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My MDS/AML has not improved after 2 treatments with specific medications.

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I am 18 years old or older.

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My kidneys are functioning well.

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I agree to use effective birth control during and up to 4 months after the study.

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I can take care of myself but might not be able to do heavy physical work.

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My AML has returned or didn't respond to treatment, and I can't have standard AML therapy.

Exclusion Criteria

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

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I have leukemia that has spread to my brain.

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I am not pregnant or breastfeeding.

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I have never taken PARP inhibitors for any condition.

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I have an active HIV, HCV, or HBV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of participants with ≥ 50% leukemic blast reduction with Talazoparib monotherapy as a marker of anti-leukemic activity.

Secondary study objectives

Determine overall response rate in study participants

Number of participants with reduction in blasts over time on study treatment

To determine the incidence of treatment-emergent adverse events

+1 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%

Alopecia

33%

Weight loss

33%

Nausea

33%

Sinus tachycardia

33%

Investigations - Other, BUN DECREASED

33%

Urinary incontinence

33%

Peripheral motor neuropathy

33%

Hyponatremia

33%

Hypoglycemia

33%

Hypothyroidism

33%

Neutrophil count decreased

33%

White blood cell decreased

33%

Scoliosis

33%

Hypokalemia

33%

Insomnia

33%

Creatinine increased

33%

Alanine aminotransferase increased

33%

Peripheral sensory neuropathy

33%

Fever

33%

Diarrhea

33%

Hypermagnesemia

33%

Lymphocyte count decreased

33%

Hypophosphatemia

33%

Gastroesophageal reflux disease

33%

Skin ulceration

33%

Nervous system disorders - Other, PARALYSIS

33%

Muscle weakness lower limb

33%

Cough

33%

Non-cardiac chest pain

33%

Skin infection

33%

Nystagmus

33%

Arthralgia

33%

Gait disturbance

33%

Edema limbs

33%

Hypertension

33%

Investigations - Other, ALT DECREASED

33%

Chills

33%

Investigations - Other, AST DECREASED

33%

Nervous system disorders - Other, HYPOTONIC

33%

Aspartate aminotransferase increased

33%

Blurred vision

33%

Constipation

33%

Pain in extremity

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

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Talazoparib Part IExperimental Treatment1 Intervention

* Talazoparib is administered orally on a daily basis * Hydroxyurea is allowed for up to two cycles per institutional guidelines

Group II: Talazoparib + Decitabine Part IIExperimental Treatment2 Interventions

* Talazoparib is administered orally on a daily basis * Hydroxyurea is allowed for up to two cycles per institutional guidelines * Decitabine on days 1-5

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1720

Talazoparib

2021

Completed Phase 2

~2810