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Anti-metabolite
Talazoparib + Chemotherapy for Acute Myeloid Leukemia (PARPAML Trial)
Phase 1
Recruiting
Led By Jennifer L Kamens, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia), specified as either refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or relapsed, and further defined as any one of the criteria below:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
PARPAML Trial Summary
This trial is a Phase 1, which means that it is the first time this drug is being tested in humans. The study is open label, which means that both the investigators and participants know what treatment is being given. The trial is multicenter, which means that it is being conducted at more than one location. The purpose of the trial is to establish the maximum tolerated dose of the combination of talazoparib and two other drugs when given together.
Who is the study for?
This trial is for children and young adults up to 21 years old with relapsed or refractory Acute Myeloid Leukemia (AML) or similar conditions. They should have had a stem cell transplant at least 60 days ago, be recovered from previous treatments, and not have uncontrolled infections or other cancer therapies ongoing. Pregnant individuals or those with certain leukemia subtypes are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Talazoparib combined with chemotherapy drugs Gemcitabine and Topotecan in pediatric AML patients. It's a Phase 1 trial that will first find the highest dose patients can tolerate without severe side effects before assessing how well it works.See study design
What are the potential side effects?
Possible side effects include reactions related to bone marrow suppression like fatigue, infection risk increase, bleeding problems, as well as nausea, vomiting, liver function changes, heart issues reflected in ejection fraction changes, and kidney function impairment.
PARPAML Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia has the same genetic features as when first diagnosed.
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My leukemia is either not responding to treatment or has come back.
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My cancer's genetic makeup has not changed significantly since diagnosis.
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My cancer is showing signs of returning, as confirmed by two tests.
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It has been over 60 days since my stem cell transplant.
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I had a stem cell transplant, have no active GVHD, and haven't taken calcineurin inhibitors for 4 weeks.
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My liver enzymes are within 5 times the normal limit.
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My bilirubin levels are within twice the normal range for my age.
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I can do most activities but may need help.
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I am 21 years old or younger.
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My cancer's genetic test shows the same abnormality as when first diagnosed.
PARPAML Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity (DLT).
Secondary outcome measures
Objective Response (OR)
Side effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT0211677789%
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%
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
PARPAML Trial Design
1Treatment groups
Experimental Treatment
Group I: Talazoparib with topotecan and gemcitabineExperimental Treatment3 Interventions
Talazoparib will be administered orally on Days 1 to 5 concurrently with topotecan and a single dose of gemcitabine on Day 1 of 28 day cycle for 1 or 2 cycles. Subjects on dose level 5 will receive an additional 5 day treatment course of talazoparib on days 15-19.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770
Gemcitabine
2017
Completed Phase 3
~2070
Topotecan
2017
Completed Phase 3
~2400
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,394 Previous Clinical Trials
17,341,576 Total Patients Enrolled
Jennifer Lauren KamensLead Sponsor
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,536 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing or planning to start any cancer treatment soon.My leukemia has the same genetic features as when first diagnosed.It's been over 24 hours since my last mild cancer treatment.It's been over 2 weeks since my last intense cancer treatment, and I feel mostly recovered.My leukemia is either not responding to treatment or has come back.People with Down syndrome cannot participate in the study.I agree not to breastfeed during the trial.My cancer's genetic makeup has not changed significantly since diagnosis.I have been diagnosed with APL or JMML.My cancer is showing signs of returning, as confirmed by two tests.It has been over 60 days since my stem cell transplant.I had a stem cell transplant, have no active GVHD, and haven't taken calcineurin inhibitors for 4 weeks.I have been diagnosed with Bone Marrow Failure Syndrome.My liver enzymes are within 5 times the normal limit.My bilirubin levels are within twice the normal range for my age.I can do most activities but may need help.I do not have any uncontrolled infections.I am 21 years old or younger.My cancer's genetic test shows the same abnormality as when first diagnosed.My white blood cell count is 50,000 or less, possibly after treatment to lower it.
Research Study Groups:
This trial has the following groups:- Group 1: Talazoparib with topotecan and gemcitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you share any other investigations that have been conducted involving Talazoparib?
"Presently, 555 clinical trials are underway to explore the efficacy of Talazoparib. Of these studies, 151 have entered Phase 3 and originate from Woolloongabba, Queensland with 29857 other sites worldwide running related experiments."
Answered by AI
Is the research team currently searching for participants to join their endeavor?
"According to clinicaltrials.gov, this trial has concluded its recruitment efforts since the last update on June 10th 2022. Having initially been posted 11 months ago on November 1st 2021, it is no longer looking for participants; however, there are still 1063 active studies seeking volunteers now."
Answered by AI
Is Talazoparib a secure course of treatment for humans?
"Talazoparib has yet to be extensively tested, so it is assigned a rating of 1 for safety. This drug is currently in its primary testing phase."
Answered by AI
For what maladies is Talazoparib typically prescribed?
"Talazoparib is widely used to treat small cell lung cancer, and has also been found effective in treating head and neck carcinoma, cervical cancers, as well as acute myelocytic leukemia."
Answered by AI
What is the participation rate for this trial?
"At present, this clinical trial is not recruiting participants. The first post was created on November 1st 2022 and the last update occurred June 10th 2022. If you are seeking alternatives to consider, there are 508 active studies looking for volunteers with leukaemia, myelocytic acute conditions as well as 555 trials actively enrolling patients interested in talazoparib treatment."
Answered by AI
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