Clinical trial NCT03564938: Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
Official title: A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Colorectal Cancer
Keywords: mCRC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
measure: Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
timeFrame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
measure: Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
timeFrame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
measure: Change in Body weight (kg)
timeFrame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
measure: Change in Body height (cm)
timeFrame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
measure: Change in Systolic / Diastolic BP (mmHg)
timeFrame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
measure: Change in heart rate (beats/min)
timeFrame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: 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
measure: Overall response rate (ORR)
timeFrame: 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
measure: Progression free survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: 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
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Apollo Research Foundation
state: Andhra Pradesh
city: New-Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Shalby Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Healthcare Center Global Hospital
state: Gujarat
city: Mumbai,
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
state: Maharashtra
city: Mumbai
country: India
facility: Sushrut Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Jehangir Hospital
state: Maharashtra
city: West-Mumbai
country: India
facility: Fortis Hospital
state: Maharashtra
city: Bhubaneswar
country: India
facility: Sparsh Hospital & Critical Care
state: Orissa
city: Madurai
country: India
facility: Apollo Speciality Hospitals
state: Tamil Nadu
city: Kolkata
country: India
facility: IPGME & R / SSKM Hospital
state: West Bengal
city: Kolkata
country: India
facility: Health Point Hospital
state: West Bengal
Study officials:
References: