← Back to Search

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
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

TAPUR Trial 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.Check my eligibility
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.See study design
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.

TAPUR Trial Eligibility Criteria

Inclusion Criteria

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

TAPUR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Overall survival (OS)

TAPUR 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
~1580
Olaparib
2007
Completed Phase 4
~2140
Nivolumab and Ipilimumab
2018
Completed Phase 2
~60
Futibatinib
2014
Completed Phase 2
~410
Palbociclib
2017
Completed Phase 3
~3710
Talazoparib
2021
Completed Phase 2
~2770
Pembrolizumab
2017
Completed Phase 2
~2010
Entrectinib
2014
Completed Phase 2
~360
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

American Society of Clinical OncologyLead Sponsor
33 Previous Clinical Trials
143,762 Total Patients Enrolled
2 Trials studying Multiple Myeloma
89 Patients Enrolled for Multiple Myeloma
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,521,981 Total Patients Enrolled
7 Trials studying Multiple Myeloma
1,418 Patients Enrolled for Multiple Myeloma
BayerIndustry Sponsor
2,232 Previous Clinical Trials
25,321,929 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 6 (mTOR, TSC), Group 17 (CDKN2A, CDK4, CDK6), Group 19 (BRCA1/2, PALB2), Group 22 (ROS1 fusion), Group 16 (MSI-H, high mutational load and others), 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

Frequently Asked Questions

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

Has this medication been federally sanctioned?

"This is a Phase 2 trial, which means that while there is some safety data, there is no efficacy data. Our team scores the safety of this treatment as a 2."

Answered by AI

Can more people still join this research project?

"From what is noted on clinicaltrials.gov, this study appears to be searching for participants at this time. The trial was originally posted on March 14th, 2016 and the most recent update was November 3rd, 2022."

Answered by AI

What is the most common purpose of this medication?

"This type of treatment is often used to manage unresectable melanoma. It may also help patients with microsatellite instability high, squamous cell carcinoma, and those at a high risk for cancer recurrence."

Answered by AI

Is this a common treatment that has been studied before?

"This intervention was first explored in a 1999 study based in Ospedale di Circolo e Fondazione Macchi. Since that initial research, there have been 1880 completed trials. As of now, 2851 clinical studies are actively recruiting patients; many of these trials are being conducted out of Kettering, Ohio."

Answered by AI

How many study participants are included in this research?

"Correct. Data hosted on clinicaltrials.gov indicates that this medical study, which was first posted on March 14th 2016, is actively recruiting patients. 3641 individuals are needed for the trial at 100 different sites."

Answered by AI

Where can people go to participate in this research?

"With 100 locations taking part in this clinical trial, there are plenty of opportunities for patients to get involved. Some notable places include Kettering Health in Kettering, The Queen's Medical Center (The University of Texas MD Anderson Cancer Center) in Honolulu, and Cancer Treatment Centers of America-Phoenix in Phoenix."

Answered by AI
Recent research and studies
~325 spots leftby Dec 2024