| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02693535 | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer | PHASE2 | RECRUITING | 4,200 | — | — | Mar 14, 2016 | Dec 31, 2028 | May 29, 2026 | 181 | United States, Puerto Rico |
Each cohort includes participants with the same tumor type, genomic variant and study drug. For solid tumors, the Response Evaluation Criteria for Solid Tumors (RECIST) criteria will be used, for non-Hodgkin Lymphoma, the Lugano Criteria will be used, and for multiple myeloma, the International Uniform Response Criteria for Multiple Myeloma will be used.
| Arm | Type | Description |
|---|---|---|
| Group 4 (CDKN2A, CDK4, CDK6) | OTHER | 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 5 (CSF1R,PDGFR,VEGFR) | OTHER | 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 6 (mTOR, TSC) | OTHER | Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations |
| Group 8 (ERBB2) | OTHER | Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations |
| Group 9 (BRAF V600E/D/K/R) | OTHER | Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations |
| Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF) | OTHER | 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 |
| Group 14 (BRCA1/2; ATM) | OTHER | 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 16 (MSI-H, high mutational load and others) | OTHER | 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 17 (CDKN2A, CDK4, CDK6) | OTHER | 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 19 (BRCA1/2, PALB2) | OTHER | Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations |
| Group 21 (BRCA1/2, PALB2, ATM, and others) | OTHER | 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 24 (ERBB2) | OTHER | 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 25 | OTHER | 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 26 (BRAF V600 E mutation ) | OTHER | Participants receive Dabrafenib plus Trametinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600 E mutation . |
| Group 27 (ERBB2 amplification, ERBB2 (HER2) IHC2+ or IHC3+ overexpression) | OTHER | Participants receive Fam-trastuzumab deruxtecan-nxki (ENHERTU®) - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification, For NSCLC Only-ERBB2 (HER2) IHC2+ or IHC3+ overexpression without ERBB2 amplification) |
| Name | Type | Description |
|---|---|---|
| Palbociclib | DRUG | drug |
| Sunitinib | DRUG | drug |
| Temsirolimus | DRUG | drug |
| Trastuzumab and Pertuzumab | DRUG | drug |
| Vemurafenib and Cobimetinib | DRUG | drug |
| Regorafenib | DRUG | drug |
| Olaparib | DRUG | drug |
| Nivolumab and Ipilimumab | DRUG | drug |
| Abemaciclib | DRUG | drug |
| Talazoparib | DRUG | drug |
| Atezolizumab and Talazoparib | DRUG | drug |
| Tucatinib plus Trastuzumab Subcutaneous (SC) | DRUG | drug |
| Futibatinib | DRUG | drug |
| Dabrafenib plus Trametinib | DRUG | Drug |
| Fam-Trastuzumab Deruxtecan-Nxki (TDxD) | DRUG | Drug |
Inclusion Criteria: * 12 years of age or older (\*Restrictions apply. Not all therapies are available for patients \<18) * Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatmen...