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

NCT01584830 | Completed Phase 3 DMC

• 1 other identifier: 15808
• Study Type: interventional
• Target: 204
• Locations: 5 countries
• Sites: 25

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

Keywords

Regorafenib; Colorectal; Metastatic

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization of the first subject untill 154 death events observed, up to 2 years

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  From randomization of the first subject untill 154 death events observed, up to 2 years

• The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).

  From randomization of the first subject untill 154 death events observed, up to 2 years

• Disease Control Rate (DCR)

  From randomization of the first subject untill 154 death events observed, up to 2 years

• Safety variables will be summarized using descriptive statistics based on adverse events collection

  From randomization of the first subject untill 154 death events observed, up to 2 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Regorafenib (BAY73-4506)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Regorafenib (BAY73-4506) DRUG

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

Arm 1

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (25)

Unknown Facility

Guangzhou, Guangdong, 510060, China

Location

Unknown Facility

Guangzhou, Guangdong, 510080, China

Location

Unknown Facility

Harbin, Heilongjiang, 150056, China

Location

Unknown Facility

Nanjing, Jiangsu, 210002, China

Location

Unknown Facility

Xi'an, Shaanxi, 710032, China

Location

Unknown Facility

Qingdao, Shandong, 266003, China

Location

Unknown Facility

Chengdu, Sichuan, 610041, China

Location

Unknown Facility

Hangzhou, Zhejiang, 310016, China

Location

Unknown Facility

Beijing, 100021, China

Location

Unknown Facility

Beijing, 100071, China

Location

Unknown Facility

Beijing, 100142, China

Location

Unknown Facility

Changchun, 130021, China

Location

Unknown Facility

Shanghai, 200030, China

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Shanghai, 200080, China

Location

Unknown Facility

Tianjin, 300060, China

Location

Unknown Facility

Shatin, New Territories, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Seoul, Korea, 138-736, South Korea

Location

Unknown Facility

Taipei, Taipei, 10016, Taiwan

Location

Unknown Facility

Taipei, 11217, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

Unknown Facility

Hanoi, Vietnam

Location

Unknown Facility

Ho Chi Minh City, 84, Vietnam

Location

Unknown Facility

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 25981818 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2016
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

CN (16); VN (3); HK (2); TW (3); KR (1)