check_circleStudy Completed

Colorectal Neoplasms

Bayer Identifier:

15808

ClinicalTrials.gov Identifier:

NCT01584830

EudraCT Number:

Not Available

EU CT Number:

Not Available
Asian subjects with metastatic colorectal cancer treated with Regorafenib or placebo after failure of standard therapy

Trial purpose

The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer.

Key Participants Requirements

Sex

Both

Age

18 - N/A

  • - Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
    - Subjects with metastatic colorectal cancer(CRC) (Stage IV).
    - Subjects must have failed at least two lines of prior treatment.
    - Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.
     -- Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
     -- Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible.
     -- Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.
     -- Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT)
    - Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
    - Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
    - Life expectancy of at least 3 months.
    - Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
  • - Prior treatment with Regorafenib.
    - Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
    - Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
    - Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
    - Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
    - Subjects with phaeochromocytoma.
    - Pleural effusion or ascites that causes respiratory compromise.
    - Arterial or venous thrombotic or embolic events.
    - Any history of or currently known brain metastases.
    - Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
    - Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.

Trial summary

Enrollment Goal
204
Trial Dates
April 2012 - January 2016
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Seoul, 138-736, Korea, Republic Of
Completed
Taipei, 10002, Taiwan
Completed
Taipei, 11217, Taiwan
Completed
Taoyuan, 333, Taiwan
Completed
Hong Kong, Hong Kong
Completed
Shatin, Hong Kong
Completed
Shanghai, 200030, China
Completed
Beijing, 100071, China
Completed
Guangzhou, 510060, China
Completed
Nanjing, 210002, China
Completed
Beijing, 100142, China
Completed
Beijing, 100021, China
Completed
Hangzhou, 310016, China
Completed
Changchun, 130021, China
Completed
Tianjin, 300060, China
Completed
Qingdao, 266003, China
Completed
Harbin, 150081, China
Completed
Shanghai, 200080, China
Completed
Shanghai, 200032, China
Completed
Chengdu, 610041, China
Completed
Guangzhou, 510080, China
Completed
Xi'an, 710032, China
Completed
Hanoi, Viet Nam
Completed
HCMC, Viet Nam
Completed
Ho Chi Minh City, Viet Nam

Primary Outcome

  • Overall Survival (OS)
    OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
    date_rangeTime Frame:
    From randomization of the first subject untill 154 death events observed, up to 2 years
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    Safety Issue:
    No

Secondary Outcome

  • Progression-free Survival (PFS)
    PFS was defined as the time from date of randomization to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
    date_rangeTime Frame:
    From randomization of the first subject untill 154 death events observed, up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
    date_rangeTime Frame:
    From randomization of the first subject untill 154 death events observed, up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Disease Control Rate (DCR)
    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
    date_rangeTime Frame:
    From randomization of the first subject untill 154 death events observed, up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    From randomization of the first subject untill 154 death events observed, up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A randomized, double-blind, placebo-controlled phase III study of Regorafenib plus best supportive care (BSC) versus placebo plus BSC in Asian subjects with metastatic colorectal cancer (CRC) who have progressed after standard therapy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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