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CDK4/6 Inhibitor

Targeted Therapy for Advanced Stage Cancer (TAPUR Trial)

Phase 2
Recruiting
Research Sponsored by American Society of Clinical Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma
For orally administered drugs, the patient must be able to swallow and tolerate oral medication
Must not have
Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination
Patients with primary brain tumors or leptomeningeal metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years
Awards & highlights

Summary

This trial is studying how well different targeted drugs work in treating patients with cancer that has progressed after other treatments and has a genomic variant that makes the tumor respond to the drug.

Who is the study for?
This trial is for people aged 12+ with advanced cancer, such as solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma. Participants must be able to take oral medication, agree to use contraception, and have a specific abnormality in their tumor genes that can be targeted by the study drugs.
What is being tested?
The TAPUR study tests FDA-approved drugs targeting specific genetic abnormalities in tumors. It aims to learn how these therapies work in real-world settings for patients with advanced stage cancers who show sensitivity to these drugs based on genomic testing.
What are the potential side effects?
Side effects vary depending on the drug but may include fatigue, digestive issues, skin reactions, blood count changes, liver function alterations and potential risks associated with targeted cancer therapy like immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced or spreading cancer, multiple myeloma, or B cell lymphoma.
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I can swallow and tolerate pills.
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I have results from a genetic or protein test for my cancer.
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I am able to get out of my bed or chair and move around.
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My blood tests for organ function are within normal ranges.
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My cancer has a genetic profile that may benefit from specific FDA approved drugs in this study.
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I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer can't be measured or found through scans or exams.
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I have a primary brain tumor or cancer that has spread to the lining of my brain.
Select...
My cancer has spread to my brain and is getting worse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 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
Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria
Secondary study objectives
Overall survival (OS)

Trial Design

17Treatment groups
Experimental Treatment
Group I: Group 9 (BRAF V600E/D/K/R)Experimental Treatment1 Intervention
Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations
Group II: Group 8 (ERBB2)Experimental Treatment1 Intervention
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Group III: Group 6 (mTOR, TSC)Experimental Treatment1 Intervention
Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations
Group IV: Group 5 (CSF1R,PDGFR,VEGFR)Experimental Treatment1 Intervention
Participants receive sunitinib - dosage, frequency and duration per label; acceptable genomic matches include CSF1R, PDGFR, VEGFR1/2/3, KIT, FLT-3, RET, FGFR1/2/3, VHL amplifications or mutations
Group V: Group 4 (CDKN2A, CDK4, CDK6)Experimental Treatment1 Intervention
Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation
Group VI: Group 25Experimental Treatment1 Intervention
Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation
Group VII: Group 24 (ERBB2)Experimental Treatment1 Intervention
Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Group VIII: Group 23 (NTRK amplification)Experimental Treatment1 Intervention
Participants receive larotrectinib - dosage, frequency and duration per label; acceptable genomic matches include NTRK1/2/3 amplification
Group IX: Group 22 (ROS1 fusion)Experimental Treatment1 Intervention
Participants receive entrectinib - dosage, frequency and duration per label; acceptable genomic matches include any ROS1 fusion
Group X: Group 21 (BRCA1/2, PALB2, ATM, and others)Experimental Treatment1 Intervention
Participants receive atezolizumab plus talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic mutations in BRCA1/2, PALB2, ATM, ATR, CHEK2, FANCA, RAD51C, NBN, MLH1, MRE11A, CDK12; positive genomic instability score reported on the Myriad MyChoice CDx test; or Genomic Loss of Heterozygosity (LOH) Score above threshold as reported on a FoundationOne CDx test or another qualifying test for TAPUR with MTB approval
Group XI: Group 20 (ERBB2)Experimental Treatment1 Intervention
Participants receive atezolizumab plus PHESGO - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression
Group XII: Group 19 (BRCA1/2, PALB2)Experimental Treatment1 Intervention
Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations
Group XIII: Group 17 (CDKN2A, CDK4, CDK6)Experimental Treatment1 Intervention
Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation
Group XIV: Group 16 (MSI-H, high mutational load and others)Experimental Treatment1 Intervention
Participants receive nivolumab and ipilimumab - dosage, frequency and duration per label; acceptable genomic matches include MSI high status, high tumor mutational burden, MLH1, MSH2/6, PMS2, EPCAM mutations, specific POLE or POLD1 mutations, BRCA1/2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1/2/3/4/5, PCNA, RPA1/2/3/4, and SSBP1 loss of function mutations
Group XV: Group 15 (POLE, POLD1)Experimental Treatment1 Intervention
Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations
Group XVI: Group 14 (BRCA1/2; ATM)Experimental Treatment1 Intervention
Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions
Group XVII: Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)Experimental Treatment1 Intervention
Participants receive regorafenib - dosage, frequency and duration per label; acceptable genomic matches include RET, VEGFR1/2/3, KIT, PDGFRβ, RAF-1, BRAF mutations or amplifications
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sunitinib
2014
Completed Phase 3
~4380
Temsirolimus
2008
Completed Phase 2
~1940
Regorafenib
2014
Completed Phase 2
~1600
Olaparib
2007
Completed Phase 4
~2190
Nivolumab and Ipilimumab
2018
Completed Phase 2
~60
Futibatinib
2014
Completed Phase 2
~410
Palbociclib
2017
Completed Phase 3
~3880
Talazoparib
2021
Completed Phase 2
~2820
Pembrolizumab
2017
Completed Phase 2
~2070
Entrectinib
2014
Completed Phase 2
~360
Abemaciclib
2019
Completed Phase 2
~1800

Find a Location

Who is running the clinical trial?

American Society of Clinical OncologyLead Sponsor
37 Previous Clinical Trials
144,358 Total Patients Enrolled
2 Trials studying Multiple Myeloma
89 Patients Enrolled for Multiple Myeloma
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,643,018 Total Patients Enrolled
7 Trials studying Multiple Myeloma
1,418 Patients Enrolled for Multiple Myeloma
BayerIndustry Sponsor
2,260 Previous Clinical Trials
25,305,654 Total Patients Enrolled
5 Trials studying Multiple Myeloma
192 Patients Enrolled for Multiple Myeloma

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02693535 — Phase 2
Multiple Myeloma Research Study Groups: Group 16 (MSI-H, high mutational load and others), Group 6 (mTOR, TSC), Group 22 (ROS1 fusion), Group 17 (CDKN2A, CDK4, CDK6), Group 19 (BRCA1/2, PALB2), Group 8 (ERBB2), Group 20 (ERBB2), Group 21 (BRCA1/2, PALB2, ATM, and others), Group 23 (NTRK amplification), Group 25, Group 4 (CDKN2A, CDK4, CDK6), Group 9 (BRAF V600E/D/K/R), Group 15 (POLE, POLD1), Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF), Group 5 (CSF1R,PDGFR,VEGFR), Group 14 (BRCA1/2; ATM), Group 24 (ERBB2)
Multiple Myeloma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02693535 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02693535 — Phase 2
~108 spots leftby Dec 2024
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