Study 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

Inclusion Criteria

- 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-- Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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.
Exclusion Criteria
- 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

Where to participate

Status	Institution	Location
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.
Time Frame:
From randomization of the first subject untill 154 death events observed, up to 2 years
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.
Time Frame:
From randomization of the first subject untill 154 death events observed, up to 2 years
Safety Issue:
No
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Time Frame:
From randomization of the first subject untill 154 death events observed, up to 2 years
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)
Time Frame:
From randomization of the first subject untill 154 death events observed, up to 2 years
Safety Issue:
No
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame:
From randomization of the first subject untill 154 death events observed, up to 2 years
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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.