Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

NCT ID: NCT01584830

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Regorafenib (BAY73-4506)

Intervention Type: DRUG

Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be given 3 weeks on/1 week off (160 mg od po.)

Interventions

Regorafenib (BAY73-4506)

Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)

Intervention Type: DRUG

Placebo

Placebo will be given 3 weeks on/1 week off (160 mg od po.)

Intervention Type: DRUG

Eligibility Criteria

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• Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Harbin, Heilongjiang, China

Nanjing, Jiangsu, China

Xi'an, Shaanxi, China

Qingdao, Shandong, China

Chengdu, Sichuan, China

Hangzhou, Zhejiang, China

Beijing, , China

Beijing, , China

Beijing, , China

Changchun, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Tianjin, , China

Shatin, New Territories, Hong Kong

Hong Kong, , Hong Kong

Seoul, Korea, South Korea

Taipei, Taipei, Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Hanoi, , Vietnam

Ho Chi Minh City, , Vietnam

Ho Chi Minh City, , Vietnam

Countries

China; Hong Kong; South Korea; Taiwan; Vietnam

References

Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW; CONCUR Investigators. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619-29. doi: 10.1016/S1470-2045(15)70156-7. Epub 2015 May 13.

Reference Type: DERIVED

PMID: 25981818 (View on PubMed)

Other Identifiers

15808

Identifier Type: -

Identifier Source: org_study_id