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Tyrosine Kinase Inhibitor
Talazoparib + Axitinib for Advanced Kidney Cancer
Phase 1 & 2
Waitlist Available
Led By Ritesh Kotecha, 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
Biopsy proven metastatic or unresectable renal cell carcinoma with clear cell component
Patients must have measurable disease by RECIST v1.1. At least one measurable lesion should not have been previously irradiated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test if a combination of two drugs is a safe and effective treatment for advanced kidney cancer.
Who is the study for?
Adults with advanced kidney cancer that's been treated before can join this trial. They must have had specific prior treatments, no severe liver issues, and be generally well enough to do daily activities. Pregnant women or those who've had certain other cancers recently can't participate.Check my eligibility
What is being tested?
The study tests a combo of two drugs, Talazoparib and Axitinib, for safety and effectiveness in treating advanced kidney cancer. The right dose of Talazoparib with fewer side effects is being sought while using a standard dose of Axitinib.See study design
What are the potential side effects?
Possible side effects include mild to moderate reactions from the drug combination. Specific side effects aren't listed but typically could involve fatigue, nausea, blood pressure changes, or liver function alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer cannot be removed by surgery and has a clear cell component.
Select...
My cancer can be measured by scans and has a spot that hasn't been treated with radiation.
Select...
I am a woman who can have children and have a negative pregnancy test.
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I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase II: Objective Response Rate
Phase Ib: Dose Limiting Toxicity
Phase Ib: Recommended dose of talazoparib in combination with standard-dose axitinib
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%
Periorbital infection
11%
Bone pain
11%
Allergic reaction
11%
Weight loss
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
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase Ib, Dose Level 3Experimental Treatment2 Interventions
3-6 participants
Group II: Phase Ib, Dose Level 2Experimental Treatment2 Interventions
3-6 participants
Group III: Phase Ib, Dose Level 1Experimental Treatment2 Interventions
3-6 participants
Group IV: Phase II, Dose ExpansionExperimental Treatment2 Interventions
Optimal Simon 2-stage Design (14 participants initially, if MTD is tolerated well then accrual will go up to 25 participants)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770
Axitinib
2020
Completed Phase 2
~3050
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,597 Total Patients Enrolled
Ritesh Kotecha, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood counts meet the required levels and I haven't had a blood transfusion in the last 21 days.I do not have unmanaged fluid buildup.I am currently on IV antibiotics for an infection.I cannot take pills, have allergies to talazoparib/axitinib, or have a condition affecting my gut's ability to absorb medications.My kidney cancer cannot be removed by surgery and has a clear cell component.My kidneys work well enough, with a filtration rate of at least 60 ml/min.My cancer can be measured by scans and has a spot that hasn't been treated with radiation.You have a bleeding disorder or unexplained blood clotting problems.I am experiencing blockage symptoms in my digestive tract.I am not using, nor plan to use, strong P-gp inhibitors 7 days before or during the study.I have been treated with both a VEGFR TKI and a PD-1/PD-L1 inhibitor.I was diagnosed with MDS or another cancer needing treatment in the last year.I have not had radiation therapy in the last 2 weeks.I am a woman who can have children and have a negative pregnancy test.I am able to get out of my bed or chair and move around.I haven't taken any cancer treatments, including experimental drugs, in the last 21 days or less.Your heart's ejection fraction is less than or equal to 50% according to an echocardiogram.My blood pressure is very high even with medication.My side effects from previous treatments are mild or being managed.My liver is functioning within the required limits.I have tested positive for hepatitis C or B.I have previously been treated with talazoparib or similar drugs.I am under 18 years old.I have been treated with axitinib before, but other similar treatments are okay.I haven't had major blood vessel problems in the last 6 months.I need steroids for my brain cancer symptoms.I am willing and able to follow the trial's treatment plan and attend all scheduled visits.I've had no more than 2 previous cancer treatments and my kidneys work well.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ib, Dose Level 1
- Group 2: Phase Ib, Dose Level 2
- Group 3: Phase Ib, Dose Level 3
- Group 4: Phase II, Dose Expansion
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.
What is the cap of participants for this experiment?
"Indeed, the information on clinicaltrials.gov attests to this trial's ongoing recruitment process, which commenced on April 6th 2020 and was last amended on August 8th 2022. The research is seeking 39 participants from 7 medical centres."
Answered by AI
To what medical conditions is Talazoparib commonly prescribed?
"Talazoparib can be utilised to combat aplastic anemia, malignancies, and severe thyroid cancer."
Answered by AI
Has the efficacy of Talazoparib been validated by other research studies?
"Talazoparib began its clinical journey at City of Hope back in 2010 and has since had 102 trials completed. Currently, 101 active studies are taking place with a concentration around Middletown, New york."
Answered by AI
How widespread is the implementation of this research endeavor?
"This trial is being conducted in seven different medical centres, including Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale and Memorial Sloan Kettering Bergen (Limited Protocol Activities)in Montvale."
Answered by AI
Are there any vacancies for this experiment still available?
"Affirmative. Clinicaltrials.gov verifies that this medical research is actively seeking participants, having been posted on April 6th 2020 and updated most recently on August 8th 2022. 39 individuals are required to be enrolled across 7 distinct locations."
Answered by AI
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