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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
Must not have
Uncontrolled effusion management
Active infection requiring parenteral antibiotic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have unmanaged fluid buildup.
Select...
I am currently on IV antibiotics for an infection.
Select...
I cannot take pills, have allergies to talazoparib/axitinib, or have a condition affecting my gut's ability to absorb medications.
Select...
I am experiencing blockage symptoms in my digestive tract.
Select...
I am not using, nor plan to use, strong P-gp inhibitors 7 days before or during the study.
Select...
My blood pressure is very high even with medication.
Select...
I have tested positive for hepatitis C or B.
Select...
I have previously been treated with talazoparib or similar drugs.
Select...
I am under 18 years old.
Select...
I have been treated with axitinib before, but other similar treatments are okay.
Select...
I need steroids for my brain cancer symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
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 • NCT02116777
100%
Fatigue
100%
Headache
67%
Platelet count decreased
67%
Hyperglycemia
67%
Anemia
67%
Back pain
33%
Alopecia
33%
Weight loss
33%
Sinus tachycardia
33%
Urinary incontinence
33%
Nausea
33%
Gastroesophageal reflux disease
33%
Peripheral motor neuropathy
33%
Investigations - Other, ALT DECREASED
33%
Hyponatremia
33%
Hypoglycemia
33%
Hypothyroidism
33%
Neutrophil count decreased
33%
Creatinine increased
33%
White blood cell decreased
33%
Scoliosis
33%
Hypokalemia
33%
Hypertension
33%
Insomnia
33%
Alanine aminotransferase increased
33%
Peripheral sensory neuropathy
33%
Fever
33%
Diarrhea
33%
Hypermagnesemia
33%
Lymphocyte count decreased
33%
Hypophosphatemia
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%
Investigations - Other, BUN DECREASED
33%
Nystagmus
33%
Arthralgia
33%
Gait disturbance
33%
Edema limbs
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%
0%
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

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
~2820
Axitinib
2020
Completed Phase 2
~3050

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,965 Previous Clinical Trials
596,997 Total Patients Enrolled
Ritesh Kotecha, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Axitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04337970 — Phase 1 & 2
Kidney Cancer Research Study Groups: Phase Ib, Dose Level 1, Phase Ib, Dose Level 2, Phase Ib, Dose Level 3, Phase II, Dose Expansion
Kidney Cancer Clinical Trial 2023: Axitinib Highlights & Side Effects. Trial Name: NCT04337970 — Phase 1 & 2
Axitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04337970 — Phase 1 & 2
~4 spots leftby Oct 2025
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