Résztvevőt keres itt: Puerto Rico2. fázis

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

A legfontosabb adatok

Ki végzi: American Society of Clinical Oncology
Hol: Cayey, Dorado, Manati, Mayagüez, Ponce és San Juan (Puerto Rico)Mind a 6 helyszín megnézéseMég 1 másik országban, 170 helyszínen
Azonosító: NCT02693535
Állapot: Toboroz
Fázis: 2. fázis
Résztvevők: 4200 fő, tervezett
Kezdés: 2016. márc. 14.
Várható befejezés: 2028. dec. 31.
A vizsgálat típusa: Beavatkozással járó, 12 csoport
A vizsgált kezelések: Sunitinib (CLOSED TO ENROLLMENT)
Trastuzumab and Pertuzumab (CLOSED TO ENROLLMENT)
Vemurafenib and Cobimetinib (CLOSED TO ENROLLMENT)
Olaparib (CLOSED TO ENROLLMENT)
Nivolumab and Ipilimumab (CLOSED TO ENROLLMENT)
Abemaciclib (CLOSED TO ENROLLMENT)
Talazoparib (CLOSED TO ENROLLMENT)
Atezolizumab and Talazoparib (CLOSED TO ENROLLMENT)
Tucatinib plus Trastuzumab Subcutaneous (SC) (CLOSED TO ENROLLMENT)
Futibatinib
Dabrafenib plus Trametinib
Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
A regiszteradat frissítve: 2026. szeptember 22.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 12 éves vagy idősebb, előrehaladott daganatos betegeket keres (szolid daganat, myeloma multiplex vagy B-sejtes non-Hodgkin-lymphoma), akiknek a daganatában olyan génelváltozás van, amelyet egy engedélyezett gyógyszer célozhat.

Életkor: 12 éves vagy idősebb. Egyes kezelések 18 év alatt nem érhetők el.
Nem: Mindkét nem.
A betegség stádiuma: Lokálisan előrehaladott vagy áttétes szolid daganat, myeloma multiplex vagy B-sejtes non-Hodgkin-lymphoma, vizsgálattal vagy képalkotással mérhető betegséggel. Általános állapot (ECOG) 0-2.
Korábbi kezelés: A szokásos daganatellenes kezelés már nem segít, vagy nincs ilyen kezelés, illetve nem javallt.
Biomarker vagy leletérték: A daganatból végzett genomikai vagy fehérje (IHC) teszt eredménye, amely olyan profilt mutat, amelyen a vizsgálat egyik gyógyszere segíthet.

A részvétel fő kizáró okai

Képalkotással vagy vizsgálattal nem mérhető betegség (például csak magasabb vérbeli daganatmarker)
Elsődleges agydaganat
Új, kezeletlen vagy előrehaladó leptomeningeális áttét
Korábban kezelt agyi áttét, ha az elmúlt 1 hónapban görcsroham vagy neurológiai állapotváltozás volt
Szájon át szedett gyógyszernél: nem tudja lenyelni és elviselni a szájon át szedett gyógyszert, vagy ismert felszívódási zavara van

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki vehet részt

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 treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated (except under the circumstance in which the TAPUR arm is designed to provide additional evidence to support an existing FDA indication)
Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG) criteria)
Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:; Absolute neutrophil count ≥ 1500 µl; Hemoglobin ≥ 9.0 g/dl; Platelets ≥ 75,000/µl; Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome; Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases); Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
Patients must have disease that can be objectively measured by physical, laboratory or radiographic exam (per RECIST v1.1 for solid tumor, Lugano criteria for non-Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma)
Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited or New York State accredited (for labs offering services to residents of NY) laboratory. Labs that have registered the test with the NIH Genetic Testing Registry or that provide a report that has been designated as optimized for TAPUR participation are preferred, but not required. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above
Ability to understand and the willingness to sign a written informed consent/assent document
Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol
For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome
Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and for a specified amount of time the last dose of study treatment, or completely abstain from sexual intercourse; Note: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have measurable and evaluable disease per RECIST v1.1

Ki nem vehet részt

Patients with previously treated brain metastases or previously treated leptomeningeal disease are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 1 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment
Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible
Patients with primary brain tumors or new, untreated or progressive leptomeningeal metastases are excluded
Patients with known progressive brain metastases are eligible but additional eligibility criteria apply; Note: there are additional exclusion criteria that may apply

Helyszínek itt: Puerto Rico

Még 1 másik országban, 170 helyszínen

PanOncology TrialsCayey, Puerto RicoContact: Natalia OrtizRésztvevőt keres
PanOncology TrialsDorado, Puerto RicoContact: Natalia OrtizRésztvevőt keres
PanOncology TrialsManati, Puerto RicoContact: Natalia OrtizRésztvevőt keres
PanOncology TrialsMayagüez, Puerto RicoContact: Natalia OrtizRésztvevőt keres
PanOncology TrialsPonce, Puerto RicoContact: Natalia OrtizRésztvevőt keres
PanOncology TrialsSan Juan, Puerto RicoContact: Natalia OrtizRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact, or if a patient, your nearest participating TAPUR site (see participating centers). ******************************************************************** Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************

A vizsgálat 12 csoportja

Group 5 (CSF1R,PDGFR,VEGFR)Egyéb csoport
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
Kezelés: Sunitinib (CLOSED TO ENROLLMENT)
Group 8 (ERBB2)Egyéb csoport
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Kezelés: Trastuzumab and Pertuzumab (CLOSED TO ENROLLMENT)
Group 9 (BRAF V600E/D/K/R)Egyéb csoport
Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations
Kezelés: Vemurafenib and Cobimetinib (CLOSED TO ENROLLMENT)
Group 14 (BRCA1/2; ATM)Egyéb csoport
Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions
Kezelés: Olaparib (CLOSED TO ENROLLMENT)
Group 16 (MSI-H, high mutational load and others)Egyéb csoport
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
Kezelés: Nivolumab and Ipilimumab (CLOSED TO ENROLLMENT)
Group 17 (CDKN2A, CDK4, CDK6)Egyéb csoport
Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation
Kezelés: Abemaciclib (CLOSED TO ENROLLMENT)
Group 19 (BRCA1/2, PALB2)Egyéb csoport
Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations
Kezelés: Talazoparib (CLOSED TO ENROLLMENT)
Group 21 (BRCA1/2, PALB2, ATM, and others)Egyéb csoport
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
Kezelés: Atezolizumab and Talazoparib (CLOSED TO ENROLLMENT)
Group 24 (ERBB2)Egyéb csoport
Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Kezelés: Tucatinib plus Trastuzumab Subcutaneous (SC) (CLOSED TO ENROLLMENT)
Group 25Egyéb csoport
Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation
Kezelés: Futibatinib
Group 26 (BRAF V600 E mutation )Egyéb csoport
Participants receive Dabrafenib plus Trametinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600 E mutation .
Kezelés: Dabrafenib plus Trametinib
Group 27 (ERBB2 amplification, ERBB2 (HER2) IHC2+ or IHC3+ overexpression)Egyéb csoport
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)
Kezelés: Fam-Trastuzumab Deruxtecan-Nxki (TDxD)