Tutkimus Amivantamabista ja mFOLFOX6:sta tai FOLFIRIsta versus setuksimabi ja mFOLFOX6 tai FOLFIRI ensilinjan hoitona potilaille, joilla on KRAS/NRAS ja BRAF villityyppinen ei-leikkauskelvoton tai metastaattinen vasemman puolen kolorektaalisyöpä (OrigAMI-2)
Satunnaistettu, avoin vaiheen 3 tutkimus amivantamabista ja mFOLFOX6:sta tai FOLFIRIsta versus setuksimabi ja mFOLFOX6 tai FOLFIRI ensilinjan hoitona osallistujille, joilla on KRAS/NRAS ja BRAF villityypin ei-leikkauksellinen tai metastaattinen vasemmanpuoleinen kolorektaalisyöpä
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Laajennettu käyttöoikeus
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Study Contact
- Puhelinnumero: 844-434-4210
- Sähköposti: Participate-In-This-Study1@its.jnj.com
Opiskelupaikat
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Amersfoort, Alankomaat, 3813 TZ
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Amsterdam, Alankomaat, 1066 CX
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Nijmegen, Alankomaat, 6525 GA
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- Radboud University Medical Center
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Rotterdam, Alankomaat, 3015 GD
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Tilburg, Alankomaat, 5022 GC
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Utrecht, Alankomaat, 3584 CX
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Anderlecht, Belgia, 1070
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Edegem, Belgia, 2650
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Ghent, Belgia, 9000
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Haine Saint Paul La Louviere, Belgia, 7100
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Kortrijk, Belgia, 8500
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Liège, Belgia, 4000
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Barretos, Brasilia, 14780 070
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Alberta
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Montreal, Quebec, Kanada, H2X 0C1
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Beijing, Kiina, 100191
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Beijing, Kiina, 100034
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Beijing, Kiina, 100050
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Changchun, Kiina, 130021
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Hangzhou, Kiina, 310009
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Hangzhou, Kiina, 310022
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Cheras, Malesia, 56000
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Avignon, Ranska, 84918
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East Brunswick, New Jersey, Yhdysvallat, 08816
- Rekrytointi
- Astera Cancer Care
-
New Brunswick, New Jersey, Yhdysvallat, 08901
- Rekrytointi
- Rutgers Cancer Institute
-
-
New Mexico
-
Albuquerque, New Mexico, Yhdysvallat, 87102
- Rekrytointi
- University of New Mexico Cancer Center
-
-
New York
-
Mineola, New York, Yhdysvallat, 11501
- Rekrytointi
- Perlmutter Cancer Center at NYU Long Island
-
New York, New York, Yhdysvallat, 10003
- Rekrytointi
- Mount Sinai
-
New York, New York, Yhdysvallat, 10032
- Rekrytointi
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
-
New York, New York, Yhdysvallat, 10016
- Rekrytointi
- NYU Langone Medical Center NYU Hematology Associates
-
New York, New York, Yhdysvallat, 10009
- Rekrytointi
- Mount Sinai West
-
Shirley, New York, Yhdysvallat, 11967
- Rekrytointi
- New York Cancer and Blood Specialists
-
The Bronx, New York, Yhdysvallat, 10461
- Rekrytointi
- Montefiore Einstein Comprehensive Cancer Center
-
Williamsville, New York, Yhdysvallat, 14221
- Rekrytointi
- University of Buffalo Kaleida Health Cancer Care
-
-
North Carolina
-
Chapel Hill, North Carolina, Yhdysvallat, 27599
- Rekrytointi
- University of North Carolina at Chapel Hill
-
-
Ohio
-
Canton, Ohio, Yhdysvallat, 44718
- Rekrytointi
- Gabrail Cancer Center
-
Cleveland, Ohio, Yhdysvallat, 44106
- Rekrytointi
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, Yhdysvallat, 44195
- Rekrytointi
- Taussig Cancer Insititute Cleveland Clinic
-
Cleveland, Ohio, Yhdysvallat, 44111
- Rekrytointi
- Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
-
Independence, Ohio, Yhdysvallat, 44131
- Rekrytointi
- Cleveland Clinic Cancer Center Independence Family Health Center
-
Mansfield, Ohio, Yhdysvallat, 44906
- Rekrytointi
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, Yhdysvallat, 44124
- Rekrytointi
- Cleveland Clinic Cancer Center Hillcrest Hospital
-
Sandusky, Ohio, Yhdysvallat, 44870
- Rekrytointi
- Cleveland Clinic Cancer Centers Sandusky
-
Strongsville, Ohio, Yhdysvallat, 44136
- Rekrytointi
- Cleveland Clinic Cancer Center Strongsville
-
Warrensville Heights, Ohio, Yhdysvallat, 44122
- Rekrytointi
- Cleveland Clinic Cancer Center South Pointe Hospital
-
Wooster, Ohio, Yhdysvallat, 44691
- Rekrytointi
- Wooster Milltown Specialty and Surgery Center
-
-
Oregon
-
Bend, Oregon, Yhdysvallat, 97701
- Rekrytointi
- St Charles Medical Center
-
Portland, Oregon, Yhdysvallat, 97239
- Rekrytointi
- Oregon Health And Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Yhdysvallat, 19111
- Rekrytointi
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Yhdysvallat, 19107
- Rekrytointi
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15232 1301
- Rekrytointi
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Nashville, Tennessee, Yhdysvallat, 37203
- Rekrytointi
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, Yhdysvallat, 79606
- Rekrytointi
- Texas Oncology West Texas
-
Dallas, Texas, Yhdysvallat, 75246
- Rekrytointi
- Texas Oncology DFW
-
Dallas, Texas, Yhdysvallat, 75390
- Rekrytointi
- UT Southwestern
-
Houston, Texas, Yhdysvallat, 77030
- Rekrytointi
- MD Anderson Cancer Center
-
Round Rock, Texas, Yhdysvallat, 78665
- Rekrytointi
- Baylor Scott and White Health 1
-
San Antonio, Texas, Yhdysvallat, 78240
- Rekrytointi
- Texas Oncology - San Antonio
-
Temple, Texas, Yhdysvallat, 76508
- Rekrytointi
- Baylor Scott and White Health
-
-
Virginia
-
Arlington, Virginia, Yhdysvallat, 22201
- Rekrytointi
- Virginia Cancer Specialists
-
Fairfax, Virginia, Yhdysvallat, 22031
- Rekrytointi
- Inova Schar Cancer Institute Dept of Fairfax Hospital
-
Richmond, Virginia, Yhdysvallat, 23249
- Rekrytointi
- Richmond VA Medical Center
-
Richmond, Virginia, Yhdysvallat, 23298
- Rekrytointi
- VCU Massey Comprehensive Cancer Center
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-
Washington
-
Edmonds, Washington, Yhdysvallat, 98026
- Rekrytointi
- Swedish Cancer Institute Edmonds
-
Issaquah, Washington, Yhdysvallat, 98029
- Rekrytointi
- Swedish Cancer Institute Issaquah
-
Seattle, Washington, Yhdysvallat, 98104
- Rekrytointi
- Swedish Cancer Institute
-
Seattle, Washington, Yhdysvallat, 98109
- Rekrytointi
- Fred Hutchinson Cancer Research Center
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-
Wisconsin
-
Madison, Wisconsin, Yhdysvallat, 53705
- Rekrytointi
- William S. Middleton Memorial VA
-
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
- Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
- Must agree to the submission of fresh tumor tissue
- Have measurable disease according to RECIST v1.1
- Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Exclusion Criteria:
- Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
- Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
- Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Arm A: Amivantamab in Combination With Chemotherapy
Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin] or FOLFIRI [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
Amivantamab will be administered.
Muut nimet:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. |
|
Active Comparator: Arm B: Cetuximab in Combination With Chemotherapy
Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. Cetuximab will be administered.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Aikaikkuna: Up to 4 years and 2 months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date. |
Up to 4 years and 2 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overall Survival (OS)
Aikaikkuna: Up to 7 Years 3 Months
|
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by BICR
Aikaikkuna: Up to 7 Years 3 Months
|
ORR is defined as the proportion of randomized participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. BOR is defined as best response recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent systemic anti cancer therapy or date of curative-intent procedure, whichever occurs first. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by Investigator
Aikaikkuna: Up to 7 Years 3 Months
|
ORR is defined as the percentage of randomized participants achieving complete CR or PR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Progression Free Survival (PFS) as Assessed by Investigator
Aikaikkuna: Up to 7 Years 3 Months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by the investigator. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable disease assessment date. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed by BICR
Aikaikkuna: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed Investigator
Aikaikkuna: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Response (TTR) as Assessed by BICR
Aikaikkuna: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR. |
Up to 7 Years 3 Months
|
|
Time to Response as Assessed by Investigator
Aikaikkuna: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator. |
Up to 7 Years 3 Months
|
|
Progression-free Survival After Subsequent Therapy (PFS2)
Aikaikkuna: Up to 7 Years 3 Months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by BICR
Aikaikkuna: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by Investigator
Aikaikkuna: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Treatment Failure
Aikaikkuna: Up to 7 Years 3 Months
|
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy. |
Up to 7 Years 3 Months
|
|
Curative Resection (R0) Rate
Aikaikkuna: Up to 7 Years 3 Months
|
Curative resection (R0) rate is defined as the proportion of participants from the analysis set who underwent curative-intent surgery, where the residual tumor classification was R0. |
Up to 7 Years 3 Months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Aikaikkuna: Up to 7 Years 3 Months
|
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. AE severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) v5.0. by using the standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. |
Up to 7 Years 3 Months
|
|
Number of Participants with Abnormalities in Laboratory Values
Aikaikkuna: Up to 7 Years 3 Months
|
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
Up to 7 Years 3 Months
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Aikaikkuna: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Aikaikkuna: Up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptom. |
Up to 7 Years 3 Months
|
|
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score
Aikaikkuna: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29
Aikaikkuna: Up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
Up to 7 Years 3 Months
|
|
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
Aikaikkuna: Up to 7 Years 3 Months
|
The EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "not at all" to 4 "very much." Higher scores indicate severe side effects. |
Up to 7 Years 3 Months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Suoliston sairaudet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Paksusuolen sairaudet
- Kolorektaaliset kasvaimet
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Camptothecin
- Alkaloidit
- Entsyymit ja koentsyymit
- Vasta -aineet, monoklonaalinen, humanisoitu
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Koordinointikompleksit
- Pyrimidiinit
- Formyyltetrahydrofolaatit
- Tetrahydrofolaatit
- Foolihappo
- Pterinit
- Pteridiinit
- Urasiili
- Pyrimidinonit
- Koentsyymit
- Oksaliplatiini
- Irinotekaani
- Setuksimabi
- Fluorourasiili
- Leukovoriini
- Levoleukovoriini
- amivantamab
Muut tutkimustunnusnumerot
- 61186372COR3001
- 2024-513852-13-00 (Rekisterin tunniste: EUCT number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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