Metastatic Colorectal Cancer
Conditions
Keywords
mCRC
Brief summary
This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.
Interventions
DRUGRegorafenib (Stivarga, BAY73-4506)
The recommended dose of regorafenib is 160 mg (consisting of 4 tablets, each containing 40 mg of regorafenib) for 3 weeks of every 4 week cycle, (ie. 3 weeks on therapy, 1 week off therapy).
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients (≥18 years of age) with metastatic (Stage IV) colorectal adenocarcinoma confirmed either histologically or cytologically, with measurable metastatic disease according to RECIST v. 1.1 * Patients must have PD after receiving the approved standard therapies * Patients must have ECOG PS of 0 or 1 and a life expectancy of at least 3 months * Adequate bone marrow, liver and renal function * Women of childbearing potential and men must agree to use adequate contraception
Exclusion criteria
* Unresolved toxicity greater than Grade 1 from prior treatment for mCRC * Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s) * Subjects unable to swallow oral medications * Any malabsorption condition * Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patient's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in heart rate (beats/min) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib |
| Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib |
| Change in Body weight (kg) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib |
| Change in Body height (cm) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib |
| Change in Systolic / Diastolic BP (mmHg) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib |
| Number of Adverse Events | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib |
| Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first | Defined as proportion of patients achieving CR, and PR per RECIST v.1.1 |
| Progression free survival (PFS) | In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first | Progression free survival is defined as the time from study drug assignment to progressive disease (PD) or death from any cause or date of last tumor assessment if the patient did not progress or die. |
| Overall survival (OS) | In each participant, every 8 weeks from the start of regorafenib until death, lost to follow-up, consent withdrawn or end of study, whichever occurs first | Overall survival is defined as the time from study drug assignment to death from any cause or last date when the patient was known to be alive. |
| Disease control rate (DCR) | In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first | Defined as proportion of patients achieving complete response (CR), partial response (PR), or SD (stable disease) per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 |
Countries
India
Outcome results
None listed