Skip to main content
OpenTrials
Completed

NCT Number: NCT03564938

Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Apollo Research Foundation, Hyderabad, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Nublexa

Primary outcomes

  1. Number of Adverse Events

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

  2. Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

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

  3. Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements

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

  4. Change in Body weight (kg)

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

  5. Change in Body height (cm)

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

  6. Change in Systolic / Diastolic BP (mmHg)

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

  7. Change in heart rate (beats/min)

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

Secondary outcomes

  1. Disease control rate (DCR)

    Time 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

    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

  2. Overall response rate (ORR)

    Time 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

    Defined as proportion of patients achieving CR, and PR per RECIST v.1.1

  3. Progression free survival (PFS)

    Time 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 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.

  4. Overall survival (OS)

    Time 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

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2018
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.