To collect the safety and efficacy data in patients with metastatic colorectalcancer after giving regorafenib in Indian patients.

A phase IV study to investigate the safety and efficacy of regorafenib in Indian patients with metastatic colorectal cancer (mCRC) - CORAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014371

Enrollment

100

Registered

2018-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- metastatic colorectal cancer mCRC

Interventions

Intervention1: Regorafenib Bay 73- 4506: 160 mg 4 tablets each containing 40 mg regorafenib once daily 3 weeks on therapy and 1 week off therapy Each 4 week period constitutes 1 cycle Oral per os-po,t

Eligibility

Inclusion criteria

Inclusion criteria: 1Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent 2 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 3 Patients must have PD after receiving the approved standard therapies 4 Patients must have ECOG PS of 0 or 1 and a life expectancy of atleast 3 months 5 Adequate bone marrow, liver and renal function; 6 Women of childbearing potential and men must agree to use adequate contraception.

Exclusion criteria

Exclusion criteria: 1 Unresolved toxicity greater than Grade 1 from prior treatment for mCRC 2 Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s) 3 Subjects unable to swallow oral medications Any malabsorption condition; 4 Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patientâ??s participation in the study.

Design outcomes

Primary

Measure	Time frame
1 AEs 2 changes in ECOG PS from baseline 3 laboratory changes 4 changes in vital signsTimepoint: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib.	—

Secondary

Measure	Time frame
1 Disease control rate defined as proportion of patients achieving CR, PR, or SD per RECIST v. 1.1; 2 Overall response rate defined as proportion of patients achieving CR and PR per RECIST v.1.1; 3 Progression free survival defined as time from treatment assignment until PD (per RECIST v. 1.1) or until death; 4 Overall survival defined as time from treatment assignment until death from any cause.Timepoint: The primary completion is reached when each patient has been treated for at least 6 months, unless he or she has discontinued treatment earlier. Since the endpoints are dependent on the underlying disease progression the time interval cannot be defined.	—

Measure

Time frame

1 Disease control rate defined as proportion of patients achieving CR, PR, or SD per RECIST v. 1.1; 2 Overall response rate defined as proportion of patients achieving CR and PR per RECIST v.1.1; 3 Progression free survival defined as time from treatment assignment until PD (per RECIST v. 1.1) or until death; 4 Overall survival defined as time from treatment assignment until death from any cause.Timepoint: The primary completion is reached when each patient has been treated for at least 6 months, unless he or she has discontinued treatment earlier. Since the endpoints are dependent on the underlying disease progression the time interval cannot be defined.

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Countries

India

Contacts

Public ContactDr Rakesh Pore

SIRO Clipharm Pvt Ltd

Somesh.Bolegave@siroclinpharm.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026