Vai al contenuto principale
xMedica

NCT07415031ClinicalTrials.gov

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC)…

Fase 2170 partecipanti ricercati100 centri20 paesi

Categorie

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Present: Registered before enrolment beganFirst posted 2026-02-17; recorded start 2026-05-06
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Not stated: Open label (no blinding)Masking is recorded as none (open label)
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 19 other studies in this databaseCounted from the lead sponsor named in the record (Mirati Therapeutics Inc.)
  • Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 100 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 170 participants (target), run at 100 sites, across 20 countries.

How this score is built
  • Enrolment21/40

    170 participants (target)

  • Site count23/25

    100 sites

  • Country count15/15

    20 countries

  • Planned duration7/10

    Planned over about 22 months

  • Sponsor scale4/10

    Mirati Therapeutics Inc. has led 19 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.

Patologie

  • Solid Tumors

Idoneità

Idoneità
SessoTutti
Età18 YearsNessun massimo
Volontari saniNo

Idoneità come riportata nel registro

Inclusion Criteria: * Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit. * Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF. Exclusion Criteria: * Participant is not eligible for study treatment per the parent study eligibility criteria. * Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study. * Participants not receiving clinical benefit from parent study drug as assessed by the investigator. Other protocol defined inclusion/exclusion criteria applies.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studioInterventistico
FaseFase 2
AssegnazioneNon applicabile
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoNONE (0)
Arruolamento170 partecipanti ricercati

Sponsor e collaboratori

  • Mirati Therapeutics Inc. Sponsor

Bracci e interventi

  • Arm A1EXPERIMENTAL
  • Arm A2EXPERIMENTAL
  • Arm B1EXPERIMENTAL
  • Arm B2EXPERIMENTAL
  • Arm B3EXPERIMENTAL
  • Arm B4EXPERIMENTAL
  • Arm C1EXPERIMENTAL
  • Arm C2EXPERIMENTAL
  • Arm C3EXPERIMENTAL
  • Arm C4EXPERIMENTAL

Interventi

  • Farmaco Adagrasib

    Specified dose on specified days

  • Farmaco Cetuximab

    Specified dose on specified days

  • Farmaco Docetaxel

    Specified dose on specified days

  • Farmaco Fluorouracil

    Specified dose on specified days

  • Farmaco Irinotecan

    Specified dose on specified days

  • Farmaco Leucovorin

    Specified dose on specified days

  • Farmaco Oxaliplatin

    Specified dose on specified days

  • Farmaco Pembrolizumab

    Specified dose on specified days

  • Farmaco Pemetrexed

    Specified dose on specified days

Esiti misurati

  1. Esito primario

    Number of Participants With Adverse Events (AEs)

    Orizzonte temporale Up to 90 days from last dose or study discontinuation

  2. Esito primario

    Number of Participants With AEs Leading to Treatment Discontinuation

    Orizzonte temporale Up to 90 days from last dose or study discontinuation

  3. Esito primario

    Number of Participants With Serious Adverse Events (SAEs)

    Orizzonte temporale Up to 90 days from last dose or study discontinuation

  4. Esito primario

    Number of Participants With AEs Leading to Death

    Orizzonte temporale Up to 90 days from last dose or study discontinuation

Date

Date
Data di inizio6 maggio 2026 (effettiva)
Conclusione primaria16 febbraio 2028 (stimata)
Conclusione16 febbraio 2028 (stimata)
Prima pubblicazione17 febbraio 2026 (effettiva)
Ultimo aggiornamento18 agosto 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaagosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

10 centri stanno reclutando

Australia

Australia
StrutturaCittàStato o regioneStato
Local Institution - 0093St LeonardsNew South WalesNon ancora in reclutamento

Belgium

Belgium
StrutturaCittàStato o regioneStato
Local Institution - 0033GhentNon ancora in reclutamento

Canada

Canada
StrutturaCittàStato o regioneStato
Local Institution - 0072VancouverBritish ColumbiaNon ancora in reclutamento

China

China
StrutturaCittàStato o regioneStato
Local Institution - 0037BeijingBeijing MunicipalityNon ancora in reclutamento
Local Institution - 0038ChangshaHunanNon ancora in reclutamento
Local Institution - 0040ChengduSichuanNon ancora in reclutamento
Local Institution - 0044HangzhouZhejiangNon ancora in reclutamento
Local Institution - 0039JinanShandongNon ancora in reclutamento
Local Institution - 0047LinyiShandongNon ancora in reclutamento
Local Institution - 0048NanchangJiangxiNon ancora in reclutamento
Local Institution - 0046NanjingJiangsuNon ancora in reclutamento
Local Institution - 0043ShanghaiShanghai MunicipalityNon ancora in reclutamento
Local Institution - 0049ShenyangLiaoningNon ancora in reclutamento
Local Institution - 0041Xi'anNon ancora in reclutamento
Local Institution - 0045XiamenFujianNon ancora in reclutamento
Local Institution - 0042ZhengzhouHenanNon ancora in reclutamento

France

France
StrutturaCittàStato o regioneStato
Local Institution - 0032AngersMaine-et-LoireNon ancora in reclutamento
Local Institution - 0091BesançonDoubsNon ancora in reclutamento
Local Institution - 0090BronRhôneNon ancora in reclutamento
Local Institution - 0085CréteilNon ancora in reclutamento
Local Institution - 0075GleizéRhôneNon ancora in reclutamento
Local Institution - 0065La TroncheIsèreNon ancora in reclutamento
Local Institution - 0059MarseilleNon ancora in reclutamento
Local Institution - 0086NiceAlpes-MaritimesNon ancora in reclutamento
Local Institution - 0076NiceAlpes-MaritimesNon ancora in reclutamento
Local Institution - 0061ParisÎle-de-France RegionNon ancora in reclutamento
Local Institution - 0103PessacAquitaineNon ancora in reclutamento
Local Institution - 0051PoitiersVienneNon ancora in reclutamento
Local Institution - 0058QuimperNon ancora in reclutamento
Local Institution - 0050Saint-HerblainLoire-AtlantiqueNon ancora in reclutamento
Local Institution - 0063Saint-HerblainLoire-AtlantiqueNon ancora in reclutamento
Local Institution - 0078Saint-MandéNon ancora in reclutamento
Local Institution - 0074StrasbourgAlsaceNon ancora in reclutamento
Local Institution - 0077ToursNon ancora in reclutamento

Germany

Germany
StrutturaCittàStato o regioneStato
Local Institution - 0012MünchenNon ancora in reclutamento

Greece

Greece
StrutturaCittàStato o regioneStato
Local Institution - 0081AthensAttikíNon ancora in reclutamento
Local Institution - 0022AttikiNon ancora in reclutamento
Local Institution - 0087ThessalonikiNon ancora in reclutamento

Hungary

Hungary
StrutturaCittàStato o regioneStato
Local Institution - 0089BudapestNon ancora in reclutamento
Local Institution - 0067BudapestNon ancora in reclutamento

Israel

Israel
StrutturaCittàStato o regioneStato
Local Institution - 0119HaifaNon ancora in reclutamento
Local Institution - 0055JerusalemJerusalemNon ancora in reclutamento
Local Institution - 0106Tel AvivNon ancora in reclutamento

Italy

Italy
StrutturaCittàStato o regioneStato
Local Institution - 0053BolognaNon ancora in reclutamento
Local Institution - 0054FlorenceNon ancora in reclutamento
Local Institution - 0052MeldolaNon ancora in reclutamento
Local Institution - 0107MilanNon ancora in reclutamento
Local Institution - 0021MilanNon ancora in reclutamento
Local Institution - 0020OrbassanoNon ancora in reclutamento
Local Institution - 0079PesaroNon ancora in reclutamento

Nella scheda del registro sono indicati altri 50 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 18 agosto 2026

    Centro rimosso

    1 site removed (100 total)

    101100

  2. 27 luglio 2026

    Centro aggiunto

    1 site added (101 total)

    100101