Clinical trial NCT02394834: An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer
Official title: An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Phase III, Randomized, Controlled Study Comparing the Efficacy and Safety of mFOLFOX6 + Bevacizumab Therapy vs. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Wild-type RAS(KRAS/NRAS) Unresectable Advanced or Recurrent Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Metastatic colorectal cancer, Panitumumab, mFOLFOX6, Bevacizumab
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 757
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study.

Brief summary: The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Detailed description: The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + mFOLFOX (PARADIGM Study: NCT02394795) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.

Eligibility criteria: Inclusion Criteria:

(1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study

Exclusion Criteria:

(1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 63 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 63 months
measure: Response Rate (RR)
timeFrame: Approximately 12 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 63 months
measure: Percentage of Participants who Proceeded to Surgical Resection
timeFrame: Up to approximately 63 month
measure: Percentage of Participants with Early Tumor Shrinkage
timeFrame: Up to approximately 63 months
measure: Degree of the Maximum Tumor Shrinkage (Depth of Response)
timeFrame: Up to approximately 63 months
measure: Evaluation of the Relationship of Each Biomarker in Plasma Free DNA and Tumor Samples at Baseline of the Main Study
timeFrame: Up to approximately 63 months
measure: Evaluation of the Relationship between Each Biomarker in Plasma Free DNA at Baseline of the Main Study, and Efficacy Endpoints
timeFrame: Up to approximately 63 months
measure: Evaluation of the Relationship between a Change in Each Biomarker in Plasma Free DNA at Baseline and the Discontinuation of the Protocol Treatment of the Main Study, and Efficacy Endpoints
timeFrame: Up to approximately 63 months
measure: Evaluation of the Relationship between a Change in Each Biomarker in Tumor Tissue at Baseline and the Discontinuation of the Protocol Treatment of the Main Study, and Efficacy Endpoints
timeFrame: Up to approximately 63 months
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
state: Aichi
city: Komaki
country: Japan
state: Aichi
city: Kounan
country: Japan
state: Aichi
city: Nagakute
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Okazaki
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Toyokawa
country: Japan
state: Aichi
city: Toyota
country: Japan
state: Aichi
city: Yatomi
country: Japan
state: Aichi
city: Daisen
country: Japan
state: Akita
city: Hirosaki
country: Japan
state: Aomori
city: Misawa
country: Japan
state: Aomori
city: Kashiwa
country: Japan
state: Chiba
city: Yachiyo
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Toon
country: Japan
state: Ehime
city: Tsuruga
country: Japan
state: Fukui
city: Yoshida
country: Japan
state: Fukui
city: Kitakyushu
country: Japan
state: Fukuoka
city: Koga
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Omuta
country: Japan
state: Fukuoka
city: Onga
country: Japan
state: Fukuoka
city: Aizuwakamatsu
country: Japan
state: Fukushima
city: Iwaki
country: Japan
state: Fukushima
city: Koriyama
country: Japan
state: Fukushima
city: Shirakawa
country: Japan
state: Fukushima
city: Hashima
country: Japan
state: Gifu
city: Kakamigahara
country: Japan
state: Gifu
city: Minokamo
country: Japan
state: Gifu
city: Ogaki
country: Japan
state: Gifu
city: Okazai
country: Japan
state: Gifu
city: Maebashi
country: Japan
state: Gunma
city: Ota
country: Japan
state: Gunma
city: Fukuyama
country: Japan
state: Hiroshima
city: Hakodate
country: Japan
state: Hokkaido
city: Kitami
country: Japan
state: Hokkaido
city: Kushiro
country: Japan
state: Hokkaido
city: Obihiro
country: Japan
state: Hokkaido
city: Otaru
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Akashi
country: Japan
state: Hyogo
city: Amagasaki
country: Japan
state: Hyogo
city: Himeji
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Hitachi
country: Japan
state: Ibaraki
city: Kasama
country: Japan
state: Ibaraki
city: Ryugasaki
country: Japan
state: Ibaraki
city: Tsuchiura
country: Japan
state: Ibaraki
city: Tsukuba
country: Japan
state: Ibaraki
city: Hakusan
country: Japan
state: Ishikawa
city: Kaga
country: Japan
state: Ishikawa
city: Kahoku
country: Japan
state: Ishikawa
city: Kanazawa
country: Japan
state: Ishikawa
city: Nanao
country: Japan
state: Ishikawa
city: Morioka
country: Japan
state: Iwate
city: Kida
country: Japan
state: Kagawa
city: Marugame
country: Japan
state: Kagawa
city: Takamatsu
country: Japan
state: Kagawa
city: Fujisawa
country: Japan
state: Kanagawa
city: Hiratsuka
country: Japan
state: Kanagawa
city: Isehara
country: Japan
state: Kanagawa
city: Kamakura
country: Japan
state: Kanagawa
city: Kanazawa
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokosuka
country: Japan
state: Kanagawa
city: Nankoku
country: Japan
state: Kochi
city: Matsuzaka
country: Japan
state: Mie
city: Tsu
country: Japan
state: Mie
city: Yokkaichi
country: Japan
state: Mie
city: Ishinomaki
country: Japan
state: Miyagi
city: Natori
country: Japan
state: Miyagi
city: Osaki
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Shibata
country: Japan
state: Miyagi
city: Matsumoto
country: Japan
state: Nagano
city: Saku
country: Japan
state: Nagano
city: Omura
country: Japan
state: Nagasaki
city: Sasebo
country: Japan
state: Nagasaki
city: Ikoma
country: Japan
state: Nara
city: Tenri
country: Japan
state: Nara
city: Yamatotakada
country: Japan
state: Nara
city: Yufu
country: Japan
state: Oita
city: Kurashiki
country: Japan
state: Okayama
city: Naha
country: Japan
state: Okinawa
city: Tomigusuku
country: Japan
state: Okinawa
city: Urasoe
country: Japan
state: Okinawa
city: Hirakata
country: Japan
state: Osaka
city: Kawachinagano
country: Japan
state: Osaka
city: Moriguchi
country: Japan
state: Osaka
city: Neyagawa
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Kawagoe
country: Japan
state: Saitama
city: Kitaadachi
country: Japan
state: Saitama
city: Koshigaya
country: Japan
state: Saitama
city: Moriyama
country: Japan
state: Shiga
city: Otsu
country: Japan
state: Shiga
city: Izumi
country: Japan
state: Shimane
city: Izumo
country: Japan
state: Shimane
city: Hamamatsu
country: Japan
state: Shizuoka
city: Izunokuni
country: Japan
state: Shizuoka
city: Sunto
country: Japan
state: Shizuoka
city: Shimotsuga
country: Japan
state: Tochigi
city: Shimotsuke
country: Japan
state: Tochigi
city: Utsunomiya
country: Japan
state: Tochigi
city: Komatsushima
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Machida
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjyuku-ku
country: Japan
state: Tokyo
city: Yonago
country: Japan
state: Tottori
city: Kurobe
country: Japan
state: Toyama
city: Takaoka
country: Japan
state: Toyama
city: Sakata
country: Japan
state: Yamagata
city: Tsuruoka
country: Japan
state: Yamagata
city: Iwakuni
country: Japan
state: Yamaguchi
city: Kofu
country: Japan
state: Yamanashi
city: Akita
country: Japan
city: Aomori
country: Japan
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Okinawa
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tokushima
country: Japan
city: Toyama
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Yoshino T, Uetake H, Tsuchihara K, Shitara K, Yamazaki K, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Yamanaka K, Iwasaki K, Soeda J, Hihara M, Yamanaka T, Ochiai A, Muro K. Rationale for and Design of the PARADIGM Study: Randomized Phase III Study of mFOLFOX6 Plus Bevacizumab or Panitumumab in Chemotherapy-naive Patients With RAS (KRAS/NRAS) Wild-type, Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2017 Jun;16(2):158-163. doi: 10.1016/j.clcc.2017.01.001. Epub 2017 Jan 24.