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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
Participants must have normal organ function as defined below: total bilirubin ≤ 2.5 × institutional upper limit of normal (unless considered to be secondary to leukemia) AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal (unless considered to be secondary to leukemia) creatinine clearance ≥ 60 mL/min/1.73 m2 Documented pathogenic mutation in cohesin complex including a mutation in STAG2, SMC1A, RAD21, PDS5B, or SMC3 gene from a CLIA-approved test (local testing allowed; will be centrally confirmed). Patient must have a minimum VAF of 5%. Historical testing (up to 3 months) allowed for treatment start on study as long as no disease-modifying agent was received since testing.
ECOG performance status ≤2 (see Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I can take care of myself but might not be able to do heavy physical work.
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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 have AML or MDS and cannot undergo intensive chemotherapy.
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I agree to use effective birth control during and up to 4 months after the study.
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My blood or bone marrow has 5% or more cancer cells.
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I am 18 years old or older.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with ≥ 50% leukemic blast reduction with Talazoparib monotherapy as a marker of anti-leukemic activity.
Secondary outcome measures
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
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%
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%
Bone pain
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

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
~1680
Talazoparib
2021
Completed Phase 2
~2770

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,731 Total Patients Enrolled
77 Trials studying Leukemia
10,408 Patients Enrolled for Leukemia
PfizerIndustry Sponsor
4,562 Previous Clinical Trials
10,907,569 Total Patients Enrolled
67 Trials studying Leukemia
15,890 Patients Enrolled for Leukemia
Jacqueline Garcia, MDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03974217 — Phase 1
Leukemia Research Study Groups: Talazoparib Part I, Talazoparib + Decitabine Part II
Leukemia Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT03974217 — Phase 1
Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03974217 — Phase 1

Frequently Asked Questions

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

What level of hazard is associated with Talazoparib administration?

"Due to its status as a Phase 1 trial, with limited safety and effectiveness data available, Talazoparib's risk profile can be rated at just 1."

Answered by AI

What is the scope of participation for this clinical research endeavor?

"Affirmative, the information on clinicaltrials.gov shows that this research project is looking for individuals to partake in their study. This particular trial was initially posted on August 1st 2019 and recently updated on July 5th 2022. They require 12 volunteers at 2 different medical centres."

Answered by AI

Are there any open slots available for participation in this clinical trial?

"Indeed, per the latest update on clinicaltrials.gov, this medical trial is still recruiting for 12 participants across two centres. The initial posting of the study was made on August 1st 2019 and has been updated as recently as July 5th 2022."

Answered by AI
~2 spots leftby Dec 2024