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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)

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En resumen

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 participantes buscados100 centros20 países

Categorías

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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.

Afecciones

  • Solid Tumors

Elegibilidad

Elegibilidad
SexoTodos
Edades18 YearsSin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el 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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudioDe intervención
FaseFase 2
AsignaciónNo aplicable
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción170 participantes buscados

Patrocinador y colaboradores

  • Mirati Therapeutics Inc. Patrocinador

Grupos e intervenciones

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

Intervenciones

  • Fármaco Adagrasib

    Specified dose on specified days

  • Fármaco Cetuximab

    Specified dose on specified days

  • Fármaco Docetaxel

    Specified dose on specified days

  • Fármaco Fluorouracil

    Specified dose on specified days

  • Fármaco Irinotecan

    Specified dose on specified days

  • Fármaco Leucovorin

    Specified dose on specified days

  • Fármaco Oxaliplatin

    Specified dose on specified days

  • Fármaco Pembrolizumab

    Specified dose on specified days

  • Fármaco Pemetrexed

    Specified dose on specified days

Variables de resultado

  1. Variable de resultado principal

    Number of Participants With Adverse Events (AEs)

    Plazo Up to 90 days from last dose or study discontinuation

  2. Variable de resultado principal

    Number of Participants With AEs Leading to Treatment Discontinuation

    Plazo Up to 90 days from last dose or study discontinuation

  3. Variable de resultado principal

    Number of Participants With Serious Adverse Events (SAEs)

    Plazo Up to 90 days from last dose or study discontinuation

  4. Variable de resultado principal

    Number of Participants With AEs Leading to Death

    Plazo Up to 90 days from last dose or study discontinuation

Fechas

Fechas
Fecha de inicio6 de mayo de 2026 (real)
Finalización principal16 de febrero de 2028 (estimada)
Finalización16 de febrero de 2028 (estimada)
Primera publicación17 de febrero de 2026 (real)
Última actualización18 de agosto de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

10 centros están en reclutamiento

Australia

Australia
CentroCiudadEstado o regiónEstado
Local Institution - 0093St LeonardsNew South WalesAún no recluta

Belgium

Belgium
CentroCiudadEstado o regiónEstado
Local Institution - 0033GhentAún no recluta

Canada

Canada
CentroCiudadEstado o regiónEstado
Local Institution - 0072VancouverBritish ColumbiaAún no recluta

China

China
CentroCiudadEstado o regiónEstado
Local Institution - 0037BeijingBeijing MunicipalityAún no recluta
Local Institution - 0038ChangshaHunanAún no recluta
Local Institution - 0040ChengduSichuanAún no recluta
Local Institution - 0044HangzhouZhejiangAún no recluta
Local Institution - 0039JinanShandongAún no recluta
Local Institution - 0047LinyiShandongAún no recluta
Local Institution - 0048NanchangJiangxiAún no recluta
Local Institution - 0046NanjingJiangsuAún no recluta
Local Institution - 0043ShanghaiShanghai MunicipalityAún no recluta
Local Institution - 0049ShenyangLiaoningAún no recluta
Local Institution - 0041Xi'anAún no recluta
Local Institution - 0045XiamenFujianAún no recluta
Local Institution - 0042ZhengzhouHenanAún no recluta

France

France
CentroCiudadEstado o regiónEstado
Local Institution - 0032AngersMaine-et-LoireAún no recluta
Local Institution - 0091BesançonDoubsAún no recluta
Local Institution - 0090BronRhôneAún no recluta
Local Institution - 0085CréteilAún no recluta
Local Institution - 0075GleizéRhôneAún no recluta
Local Institution - 0065La TroncheIsèreAún no recluta
Local Institution - 0059MarseilleAún no recluta
Local Institution - 0086NiceAlpes-MaritimesAún no recluta
Local Institution - 0076NiceAlpes-MaritimesAún no recluta
Local Institution - 0061ParisÎle-de-France RegionAún no recluta
Local Institution - 0103PessacAquitaineAún no recluta
Local Institution - 0051PoitiersVienneAún no recluta
Local Institution - 0058QuimperAún no recluta
Local Institution - 0050Saint-HerblainLoire-AtlantiqueAún no recluta
Local Institution - 0063Saint-HerblainLoire-AtlantiqueAún no recluta
Local Institution - 0078Saint-MandéAún no recluta
Local Institution - 0074StrasbourgAlsaceAún no recluta
Local Institution - 0077ToursAún no recluta

Germany

Germany
CentroCiudadEstado o regiónEstado
Local Institution - 0012MünchenAún no recluta

Greece

Greece
CentroCiudadEstado o regiónEstado
Local Institution - 0081AthensAttikíAún no recluta
Local Institution - 0022AttikiAún no recluta
Local Institution - 0087ThessalonikiAún no recluta

Hungary

Hungary
CentroCiudadEstado o regiónEstado
Local Institution - 0089BudapestAún no recluta
Local Institution - 0067BudapestAún no recluta

Israel

Israel
CentroCiudadEstado o regiónEstado
Local Institution - 0119HaifaAún no recluta
Local Institution - 0055JerusalemJerusalemAún no recluta
Local Institution - 0106Tel AvivAún no recluta

Italy

Italy
CentroCiudadEstado o regiónEstado
Local Institution - 0053BolognaAún no recluta
Local Institution - 0054FlorenceAún no recluta
Local Institution - 0052MeldolaAún no recluta
Local Institution - 0107MilanAún no recluta
Local Institution - 0021MilanAún no recluta
Local Institution - 0020OrbassanoAún no recluta
Local Institution - 0079PesaroAún no recluta

En el registro figuran 50 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 18 de agosto de 2026

    Centro eliminado

    1 site removed (100 total)

    101100

  2. 27 de julio de 2026

    Centro añadido

    1 site added (101 total)

    100101