Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02023333|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : November 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Adenocarcinoma||Drug: Regorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
This is an open-label, phase II study of regorafenib for patients with metastatic colorectal carcinoma. The treatment will be repeated every week for three weeks on and one week off. Patients will be evaluated for response after every 2 cycles (8 weeks).
All patients that meet the eligibility criteria who have signed informed consent and have enrolled on the trial will be treated with regorafenib, daily 3 weeks on 1 week off for all cycles. Dose will be escalated to 120 mg in week 2 of cycle 1 and all remaining cycles if no excess toxicity is experienced by the patient at the discretion of the treating physician.
Other Name: BAY 73-45060
- progression free survival [ Time Frame: 16 weeks ]Response and progression will be evaluated in this study using the international criteria proposed by the RECIST 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.
- overall survival [ Time Frame: 2 years ]Overall survival is defined as the time from treatment start to death or last follow up. Survival will be estimated using the Kaplan-Meier method.
- disease control rate [ Time Frame: 16 weeks ]Disease control rate (defined with RECIST 1.1 criteria at 16 weeks (2nd scan) as CR, PR or SD), will be estimated using proportions and exact binomial 95% confidence intervals provided.
- duration of stable disease [ Time Frame: 2 years ]Duration of stable disease will be defined as the time from stable disease to the time of documented progression.
- toxicity [ Time Frame: 2 years ]will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0. The assessments will be based on recorded adverse events, physical examinations, and clinical laboratory assessments. Toxicity will be summarized using descriptive statistics.
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): NCT02023333
|United States, New Jersey|
|Memorial Sloan Kettering Cancer Center at Basking Ridge|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Downstate Medical Center|
|Brooklyn, New York, United States, 11203|
|Memorial Sloan Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Queens Cancer Center of Queens Hospital|
|Jamaica, New York, United States, 11432|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Memorial Sloan Kettering Cancer Center Sleepy Hollow|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Andrea Cercek, MD||Memorial Sloan Kettering Cancer Center|