check_circleStudy Completed

metastatic colorectal cancer

Bayer Identifier:

19214

ClinicalTrials.gov Identifier:

NCT03564938

EudraCT Number:

Not Available

EU CT Number:

Not Available
Regorafenib in Indian patients with metastatic colorectal cancer (mCRC).

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
100
Trial Dates
July 2018 - December 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Fortis HospitalWest-Mumbai, 400078, India
Withdrawn
The Gujarat Cancer & Research InstituteAhmedabad, 380016, India
Completed
Health Point HospitalKolkata, 700025, India
Withdrawn
Indraprastha Apollo HospitalNew Delhi, India
Completed
Tata Memorial HospitalMumbai,, 400012, India
Withdrawn
HCG-City Cancer CentreVijayawada, 520004, India
Withdrawn
Healthcare Global Enterprises LtdBengaluru, 560027, India
Withdrawn
Manipal HospitalBangalore, 560017, India
Completed
Sir Ganga Ram HospitalNew-Delhi, 110060, India
Completed
IPGME & R / SSKM HospitalKolkata, 700020, India
Completed
Apollo Speciality HospitalsMadurai, 625020, India
Completed
Jaslok Hospital and Research CentreMumbai, 400026, India
Completed
Jehangir HospitalPune, 411001, India
Withdrawn
Amrita Institute of Medical SciencesKochi, 682026, India
Completed
Healthcare Center Global HospitalAhmedabad, 380060, India
Completed
Sparsh Hospital & Critical CareBhubaneswar, 751007, India
Completed
Shalby HospitalAhmedabad, 380054, India
Completed
Sushrut Hospital & Research CentreMumbai, 400071, India
Completed
Apollo Research FoundationHyderabad, 500096, India
Withdrawn
BLK Super Speciality HospitalNew Delhi, 11005, India

Primary Outcome

  • Number of Adverse Events
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
  • Change in Body weight (kg)
    date_rangeTime Frame:
    From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
  • Change in Body height (cm)
    date_rangeTime Frame:
    From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
  • Change in Systolic / Diastolic BP (mmHg)
    date_rangeTime Frame:
    From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
  • Change in heart rate (beats/min)
    date_rangeTime Frame:
    From the start of regorafenib treatment up to 30 days after the last dose of regorafenib

Secondary Outcome

  • Disease control rate (DCR)
    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
    date_rangeTime Frame:
    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
  • Overall response rate (ORR)
    Defined as proportion of patients achieving CR, and PR per RECIST v.1.1
    date_rangeTime Frame:
    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 (PFS)
    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.
    date_rangeTime Frame:
    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
  • Overall survival (OS)
    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.
    date_rangeTime Frame:
    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

Trial design

A phase IV study to investigate the safety and efficacy of regorafenib in Indian patients with metastatic colorectal cancer (mCRC).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here to find further information and, after study completion, they study results according to Bayer's transparency standards.Study_Synopsis-19214.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (255.0), Protocol (38.2), Results(0.1)