NCT03564938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_4

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

4.6 years

First QC Date

May 24, 2018

Last Update Submit

November 29, 2024

Conditions

Metastatic Colorectal Cancer

Keywords

mCRC

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • Change in heart rate (beats/min)

    From the start of regorafenib treatment up to 30 days after the last dose of regorafenib

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Regorafenib (Stivarga, BAY 73-4506)

EXPERIMENTAL

Patients with metastatic colorectal cancer

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506)DRUG

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).

Also known as: Nublexa
Regorafenib (Stivarga, BAY 73-4506)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Apollo Research Foundation

Hyderabad, Andhra Pradesh, 500096, India

Location

Shalby Hospital

Ahmedabad, Gujarat, 380054, India

Location

Healthcare Center Global Hospital

Ahmedabad, Gujarat, 380060, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, 400026, India

Location

Sushrut Hospital & Research Centre

Mumbai, Maharashtra, 400071, India

Location

Jehangir Hospital

Pune, Maharashtra, 411001, India

Location

Fortis Hospital

West-Mumbai, Maharashtra, 400078, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Sparsh Hospital & Critical Care

Bhubaneswar, Odisha, 751007, India

Location

Apollo Speciality Hospitals

Madurai, Tamil Nadu, 625020, India

Location

IPGME & R / SSKM Hospital

Kolkata, West Bengal, 700020, India

Location

Health Point Hospital

Kolkata, West Bengal, 700025, India

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 21, 2018

Study Start

July 30, 2018

Primary Completion

March 20, 2023

Study Completion

December 1, 2023

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

IN(13)