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Trial record 93 of 179 for:    colon cancer | ( Map: New Jersey, United States )

Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo‑Controlled Phase-III STudy (COAST)

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ClinicalTrials.gov Identifier: NCT01939223
Recruitment Status : Terminated
First Posted : September 11, 2013
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Regorafenib (Stivarga, BAY73-4506) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients With Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases
Actual Study Start Date : December 2, 2013
Actual Primary Completion Date : August 29, 2016
Actual Study Completion Date : August 29, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: Regorafenib
4 regorafenib tablets taken orally in the morning daily, followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days.
Drug: Regorafenib (Stivarga, BAY73-4506)
Four tablets of 40mg taken orally daily in the morning, dose of 160 mg for 21 days of treatment followed by 7 days without treatment

Placebo Comparator: Placebo
4 placebo tablets taken orally in the morning daily,followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days.
Drug: Placebo
Four tablets taken in the morning orally daily for 21 days of treatment followed by 7 days without treatment




Primary Outcome Measures :
  1. Disease Free Survival (DFS) as Assessed by the Investigator [ Time Frame: From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. ]
    Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn. ]
    Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a history of a primary adenocarcinoma of the colon and / or rectum
  • Have a history of Stage IV Colorectal Cancer (CRC) with metastases to the liver only
  • Have received at least 3 months ,of neoadjuvant, adjuvant, or perioperative chemotherapy, including a fluoropyrimidine and either oxaliplatin or irinotecan or both for subjects with initial Stage IV CRC which were treated with surgery with curative intent for both primary and metastatic lesions. The total chemotherapy administered, including that administered prior to and after liver resection, should not exceed 9 months. OR Have received surgery with curative intent for primary CRC and at least 3 months ,of neoadjuvant, adjuvant, or perioperative chemotherapy for the primary tumor, including a fluoropyrimidine or a fluoropyrimidine and either oxaliplatin or irinotecan or both

    • For subjects with liver metastases developing > 6 months after completing treatment for primary CRC and having undergone surgery with curative intent for liver metastases, a second course of chemotherapy lasting at least 3 months needs to be administered, including a fluoropyrimidine and either oxaliplatin or irinotecan or both. The second course of chemotherapy should not exceed 9 months.
  • For subjects who developed liver metastases >/=6 months after completing treatment for primary CRC and having undergone surgery with curative intent for liver metastases, a second course of chemotherapy is not permitted unless initial adjuvant therapy consisted of fluoropyrimidine monotherapy. Subjects who received fluoropyrimidine alone must have received a second course of chemotherapy with fluoropyrimidine and either oxaliplatin or irinotecan or both, which should not exceed 9 months.For subjects with initial Stage I or II disease, no chemotherapy is required for a primary CRC lesion treated with surgery with curative intent. These subjects must receive chemotherapy for the treatment of liver metastases (which were also treated with surgery with curative intent), which must last at least 3 months, including a fluoropyrimidine and either oxaliplatin or irinotecan or both. The total course of chemotherapy should not exceed 9 months.
  • Prior to randomization, have histological confirmation that CRC lesions were adenocarcinoma (subtypes of adenocarcinoma, e.g. mucinous adenocarcinoma are allowed). Subjects with CRC lesions of other histological types, including mixed type with predominant adenocarcinoma, will not be eligible to be randomized to study treatment.
  • Have pathology-proven complete removal of all primary and liver metastatic CRC lesions. Subjects with positive margins will not be eligible for the study.
  • Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:

    • Total bilirubin </=1.5 times the upper limit of normal (ULN)
    • Alanine aminotransferase and aspartate aminotransferase </= 3 times the ULN
    • Lipase</=1.5 times the ULN
    • Serum creatinine</=1.5 times the ULN
    • Carcinoembryonic antigen (CEA)</=3 times the ULN
    • Glomerular filtration rate>/=30 mL/min/1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula
    • International normalized ratio of prothrombin time and activated partial thromboplastic time </=1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.
    • Platelet count >/=100,000 /mm3, hemoglobin >/=9 g/dL, absolute neutrophil count >/= 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors
    • Alkaline phosphatase ≤ 2.5 times the ULN
  • Have had a CT or MRI scan (chest, abdomen, pelvis and other suspected sites as applicable) to determine eligibility for randomization within 4 weeks prior to randomization (hereafter referred to as the "eligibility scan")
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days prior to the initiation of study treatment
  • If female and of childbearing potential, or if male, agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.

Exclusion Criteria:

  • Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort).
  • Have used biologic response modifiers, such as granulocyte-colony stimulating factor, within 3 weeks prior to signing the ICF.
  • Have had prior treatment with regorafenib or any other (vascular endothelial growth factor receptor) VEGFR-targeting kinase inhibitor.
  • Have had anti-cancer treatment following liver resection that exceeded a duration of 6 months.
  • Have been treated with biologics (eg, antibodies targeting VEGFR or EGFR) after liver resection unless the administration of the biologic started prior to liver resection and continued after liver resection only to complete a pre-specified number of cycles.
  • Completed their last dose of chemotherapy or had their last cancer surgery more than 10 weeks, whichever came later, prior to randomization.
  • Have extra-hepatic metastatic disease. Suspicious lesions should be rigorously evaluated with other imaging techniques and/or biopsy to exclude extra-hepatic metastatic disease prior to submitting for central radiology review.
  • Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and/or hormonal therapy within 4 weeks prior to initiation of study treatment.
  • Are pregnant and or breast feeding.
  • Have had prior or concurrent cancer distinct in primary site or histology from CRC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer, Stage 0 intramucosal gastric cancer after endoscopic complete removal, or superficial bladder tumors classified as noninvasive tumor (Ta), carcinoma in situ (Tis), or tumor invades lamina propria (T1).
  • Have congestive heart failure classified as New York Heart Association Class 2 or higher.Have had unstable angina (angina symptoms at rest) or new-onset angina ≤ 3 months prior to screening. Have had a myocardial infarction < 6 months prior to initiation of study treatment.
  • Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin.
  • Have uncontrolled hypertension (systolic blood pressure [SBP] greater than140 mmHg or diastolic blood pressure [DBP] greater than 90 mmHg) despite optimal medical management.
  • Have pheochromocytoma.
  • Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months prior to the initiation of study treatment.
  • Have a known history of human immunodeficiency virus infection.
  • Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy.
  • Have a seizure disorder requiring medication.
  • Have evidence or history of any bleeding diathesis (including mild hemophilia), irrespective of severity.
  • Have had a hemorrhage or a bleeding event >/=Grade 3 (NCI-CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment.
  • Have any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939223


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Locations
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United States, California
Laguna Hills, California, United States, 92653
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90089
Los Angeles, California, United States, 90095
United States, Connecticut
New Haven, Connecticut, United States, 06520-8064
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore, Maryland, United States, 21201-1595
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Nebraska
Omaha, Nebraska, United States, 68106
United States, New Jersey
New Brunswick, New Jersey, United States, 08903-2681
United States, New York
Buffalo, New York, United States, 14263-0001
New York, New York, United States, 10021
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
Germantown, Tennessee, United States, 38138
United States, Texas
Dallas, Texas, United States, 75390
United States, Virginia
Richmond, Virginia, United States, 23298-0037
United States, Washington
Kirkland, Washington, United States, 98034
Seattle, Washington, United States, 98101
Seattle, Washington, United States, 98109
Australia, New South Wales
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
East Melbourne, Victoria, Australia, 3002
Australia
Bentleigh East, Australia, 3165
Malvern, Australia, 3144
Belgium
Edegem, Belgium, 2650
Leuven, Belgium, 3000
Liege, Belgium, 4000
Brazil
Belo Horizonte, Minas Gerais, Brazil, 30110-090
Porto Alegre, Rio Grande do Sul, Brazil
São José do Rio Preto, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil, 01246-000
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Montreal, Canada, H2W 1S6
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangzhou, Guangdong, China, 510060
Guangzhou, Guangdong, China, 510655
China, Heilongjiang
Harbin, Heilongjiang, China
China, Hubei
Wuhan, Hubei, China, 430033
China, Hunan
Changsha, Hunan, China, 410008
China, Shaanxi
Xi'an, Shaanxi, China, 710032
Xi'an, Shaanxi, China, 710038
China, Yunnan
Kunming, Yunnan, China, 650118
China, Zhejiang
Hangzhou, Zhejiang, China, 310009
Hangzhou, Zhejiang, China, 310016
China
Beijing, China, 100021
Beijing, China, 100071
Beijing, China, 100142
Beijing, China, 100730
Shanghai, China, 200030
Shanghai, China, 200032
Shanghai, China, 200127
France
Bordeaux, France, 33076
Brest, France, 29285
Clermont-Ferrand, France, 63000
LYON Cedex 08, France, 69373
Marseille, France, 13385
Paris, France, 75651
Poitiers Cedex, France, 86021
Tours, France, 37044
Villejuif, France, 94800
Germany
München, Bayern, Germany, 81377
Frankfurt, Hessen, Germany, 60590
Oldenburg, Niedersachsen, Germany, 26133
Mainz, Rheinland-Pfalz, Germany, 55131
Berlin, Germany, 12200
Israel
Haifa, Israel, 3109601
Ramat Gan, Israel, 52482
Tel Aviv, Israel, 64239
Italy
Napoli, Campania, Italy, 80131
Reggio Emilia, Emilia-Romagna, Italy, 42123
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00189
Brescia, Lombardia, Italy, 25124
Milano, Lombardia, Italy, 20089
Milano, Lombardia, Italy, 20133
Milano, Lombardia, Italy, 20141
Foggia, Puglia, Italy, 71013
Firenze, Toscana, Italy, 50134
Pisa, Toscana, Italy, 56126
Japan
Kashiwa, Chiba, Japan, 277-8577
Sapporo, Hokkaido, Japan, 006-8555
Sapporo, Hokkaido, Japan, 060-0004
Sapporo, Hokkaido, Japan, 060-8648
Akashi, Hyogo, Japan, 673-8558
Amagasaki, Hyogo, Japan, 660-8511
Kobe, Hyogo, Japan, 650-0047
Kasama, Ibaraki, Japan, 309-1793
Yokohama, Kanagawa, Japan, 241-8515
Suita, Osaka, Japan, 565-0871
Takatsuki, Osaka, Japan, 569-8686
Sunto, Shizuoka, Japan, 411-8777
Shimotsuke, Tochigi, Japan, 329-0498
Koto-ku, Tokyo, Japan, 135-8550
Minato-ku, Tokyo, Japan, 105-8471
Mitaka, Tokyo, Japan, 181-8611
Shinagawa, Tokyo, Japan, 142-8666
Shinjuku-ku, Tokyo, Japan, 160-8582
Fukuoka, Japan, 810-8563
Fukuoka, Japan, 811-1395
Fukuoka, Japan, 812-8582
Portugal
Almada, Portugal, 2801-951
Porto, Portugal, 4200-072
Santa Maria da Feira, Portugal, 4520-531
Spain
Alicante, Spain, 03010
Badajoz, Spain, 06080
Barcelona, Spain, 08036
Córdoba, Spain, 14004
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28040
Valencia, Spain, 46009
Valencia, Spain, 46013
United Kingdom
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, United Kingdom, SM2 5PT
Bristol, United Kingdom, BS2 8ED
London, United Kingdom, SW3 6JJ
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01939223     History of Changes
Other Study ID Numbers: 15983
2012-004369-42 ( EudraCT Number )
First Posted: September 11, 2013    Key Record Dates
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Stage IV colorectal cancer / Liver Metastasis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes