Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Kontakt
Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
Studienlocations (3 von 53)
Asklepios Klinik Altona 22763 Hamburg (Hamburg) GermanyRekrutierend» Google-MapsLudwig-Maximilians-Universitaet Muenchen 81377 Munich (Bayern) GermanyRekrutierend» Google-MapsO Neal Comprehensive Cancer Center at UAB 35233 Birmingham United StatesRekrutierend» Google-Maps
University of Southern California 90033 Los Angeles United StatesRekrutierend» Google-MapsUniversity of California, Los Angeles UCLA 90404 Los Angeles United StatesRekrutierend» Google-MapsGeorgetown University Hospital 20007 Washington United StatesRekrutierend» Google-MapsH. Lee Moffitt Cancer Center 33612 Tampa United StatesRekrutierend» Google-MapsUniversity of Maryland School of Medicine 21201 Baltimore United StatesRekrutierend» Google-MapsUniversity of Michigan Health System 48103 Ann Arbor United StatesRekrutierend» Google-MapsStart Midwest 49546 Grand Rapids United StatesRekrutierend» Google-MapsHattiesburg Clinic 39401 Hattiesburg United StatesRekrutierend» Google-MapsNYU Langone Long Island Clinical Research Associates 10016 New York United StatesRekrutierend» Google-MapsHerbert Irving Comprehensive Cancer Center, Columbia University Medical Center 10032 New York United StatesRekrutierend» Google-MapsStephenson Cancer Center 73104 Oklahoma City United StatesRekrutierend» Google-MapsVanderbilt - Ingram Cancer Center 37232 Nashville United StatesRekrutierend» Google-MapsMD Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-MapsInstitut Jules Bordet 1070 Anderlecht BelgiumRekrutierend» Google-MapsCliniques Universitaires Saint Luc 1200 Bruxelles BelgiumRekrutierend» Google-MapsUZ Antwerpen 2650 Edegem BelgiumRekrutierend» Google-MapsUniversitair Ziekenhuis Gasthuisberg 3000 Leuven BelgiumRekrutierend» Google-MapsBC Cancer Agency - Vancouver BC V5Z 4E6 Vancouver CanadaRekrutierend» Google-MapsThe Ottawa Hospital Cancer Centre K1H 8L6 Ottawa CanadaRekrutierend» Google-MapsPrincess Margaret Cancer Centre University Health Network M5G 1X6 Toronto CanadaRekrutierend» Google-MapsThe Second Hospital To Dalian Medical University 116023 Da Lian Shi ChinaRekrutierend» Google-MapsSun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital 510655 Guangzhou ChinaRekrutierend» Google-MapsThe Second Affiliated Hospital of Zhejiang University College of Medicine 310003 Hangzhou ChinaRekrutierend» Google-MapsHubei province tumor hospital 430079 Wu Han Shi ChinaRekrutierend» Google-MapsFondazione IRCCS Istituto Nazionale dei Tumori 20133 Milano ItalyRekrutierend» Google-MapsA O Ospedale Niguarda Ca Granda 20162 Milano ItalyRekrutierend» Google-MapsAzienda Ospedaliero Universitaria Pisana 56126 Pisa ItalyRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsThe Catholic University of Korea Seoul St. Mary's Hospital 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsUniversity Malaya Medical Centre 59100 Kuala Lumpur MalaysiaRekrutierend» Google-MapsHospital Umum Sarawak 93586 Kuching MalaysiaRekrutierend» Google-MapsBeacon Hospital Sdn Bhd 46050 Petaling Jaya MalaysiaRekrutierend» Google-MapsAd-Vance Medical Research 00717 Ponce Puerto RicoRekrutierend» Google-MapsPan American Center for Oncology Trials LLC 00935 Rio Piedras Puerto RicoRekrutierend» Google-MapsHosp. Univ. Vall D Hebron 08035 Barcelona SpainRekrutierend» Google-MapsHosp. Gral. Univ. Gregorio Maranon 28007 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Ramon Y Cajal 28034 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Fund. Jimenez Diaz 28040 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Hm Sanchinarro 28050 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Marques de Valdecilla 39008 Santander SpainRekrutierend» Google-MapsHosp. Clinico Univ. de Valencia 46010 Valencia SpainRekrutierend» Google-MapsChanghua Christian Hospital 500 Changhua TaiwanRekrutierend» Google-MapsKaohsiung Chang Gung Memorial Hospital 83301 Kaohsiung TaiwanRekrutierend» Google-MapsChi Mei Medical Center - Liu Ying 736 Liou Ying Township TaiwanRekrutierend» Google-MapsNational Cheng Kung University Hospital 704 Tainan TaiwanRekrutierend» Google-MapsNational Taiwan University Hospital 10002 Taipei TaiwanRekrutierend» Google-MapsLinkou Chang Gung Memorial Hospital 33305 Taoyuan TaiwanRekrutierend» Google-Maps
1. Cohorts A, B, and C: Objective Response Rate (ORR) (Time Frame - Up to 4 years 3 months): ORR is defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR), as defined by investigator assessment using Response Criteria in Solid Tumors (RECIST) version 1.1.
2. Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT) (Time Frame - Up to 4 years 3 months): Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
3. Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity (Time Frame - Up to 4 years 3 months): Number of participants with DLT by severity will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, graded as Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
4. Cohorts D and E: Number of Participants with Adverse Events (AE) (Time Frame - Up to 4 years 3 months): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the NCI CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening and Grade 5: death related to adverse event.
5. Cohorts D and E: Number of Participants with Laboratory Values Abnormalities (Time Frame - Up to 4 years 3 months): Number of participants with laboratory values abnormalities, which includes serum chemistry, hematology, coagulation, and urinalysis, will be reported.
6. Cohorts D and E: Number of Participants with Vital Signs Abnormalities (Time Frame - Up to 4 years 3 months): Number of participants with vital signs including temperature, heart rate, respiratory rate, and blood pressure (systolic and diastolic) and oxygen saturation, abnormalities will be reported.
Secondary outcome:
1. Cohorts A, B, C, Ph1b-D, and Ph1b-E: Number of Participants with AEs (Time Frame - Up to 4 years 3 months): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the NCI CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening and Grade 5: death related to adverse event.
2. Cohorts A, B, C, Ph1b-D, and Ph1b-E: Number of Participants with Laboratory Values Abnormalities (Time Frame - Up to 4 years 3 months): Number of participants with laboratory values abnormalities, which includes serum chemistry, hematology, coagulation, and urinalysis, will be reported.
3. Cohorts A, B, C, Ph1b-D, and Ph1b-E: Number of Participants with Vital Signs Abnormalities (Time Frame - Up to 4 years 3 months): Number of participants with vital signs including temperature, heart rate, respiratory rate, and blood pressure (systolic and diastolic) and oxygen saturation, abnormalities will be reported.
4. Cohorts Ph1b-D, Ph1b-E, D, and E: ORR (Time Frame - Up to 4 years 3 months): ORR is defined as the percentage of participants who achieve either a PR or CR, as defined by investigator assessment using RECIST version 1.1.
5. Cohorts Ph1b-D, Ph1b-E, D, and E: Duration of Response (DoR) (Time Frame - Up to 4 years 3 months): DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as defined by investigator assessment using RECIST version 1.1.
6. Cohorts Ph1b-D, Ph1b-E, D, and E: Clinical Benefit Rate (CBR) (Time Frame - Up to 4 years 3 months): CBR is defined as the percentage of participants achieving complete or partial response, as well as durable stable disease (defined as a duration of at least 11 weeks) as defined by RECIST version 1.1.
7. Cohorts D and E: Progression Free Survival (PFS) (Time Frame - Up to 4 years 3 months): PFS is defined as the time from the first administration of study treatment until the date of objective disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1.
Experimental: Cohorts A, B, and C: Amivantamab Monotherapy Participants with left-sided colorectal cancer (CRC) in Cohort A (no prior anti-epidermal growth factor receptor [EGFR] therapy) and in Cohort B (post anti-EGFR therapy), and right-sided CRC in Cohort C (with or without anti-EGFR therapy), will be administered intravenous (IV) infusion of amivantamab 1050 milligrams (mg) if body weight (BW) is less than (<) 80 kilograms (kg) or 1400 mg if BW is greater than or equal to (>=) 80 kg, as monotherapy on Days 1 and 15 of Cycle 2 (28-days cycle).
Active Comparator: Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) Participants who are anti-EGFR treatment naïve, have not received oxaliplatin-based chemotherapy in the metastatic setting, will be administered IV infusion of amivantamab 1050 or 700 mg (dose level 0 [DL0]) if BW is <80 kg, or 1400 or 1050 mg (dose de-escalation [DL-1]) if BW is >= 80 kg, on Days -1, -2, 8 and 22 of Cycle 1 and along with mFOLFOX6 SOC chemotherapy on Days 1 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 (each cycle of 28 days) in Phase 1b dose confirmation Cohort (Cohort Ph1b-D). Participant in Phase 2 Cohort (Cohort D) will receive recommended Phase 2 combination dose (RP2CD) of amivantamab along with mFOLFOX6 SOC chemotherapy determined in Cohort Ph1b-D.
Active Comparator: Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Participants who are anti-EGFR treatment naïve, have not received irinotecan-based chemotherapy in the metastatic setting, will be administered IV infusion of amivantamab along with FOLFIRI SOC chemotherapy on Days -1, -2, and 8 of Cycle 1 and Days 1 and 15 of Cycle 2 in Ph1b-E. For Cohort E, RP2CD determined in Ph1b-E will be administered.
