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Study Comparing Different Dose Approaches of Induction Treatment of Regorafenib in MCRC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study Comparing Different Dose Approaches of Induction Treatment of Regorafenib in MCRC

A Randomized Phase 2 Study Comparing Different Dose Approaches of Induction Treatment (First Cycle) of Regorafenib in Metastatic Colorectal Cancer (mCRC) Patients

NCT02835924•Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and tolerability of different dose-escalation approaches of regorafenib in mCRC patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent (IC) obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.
•2. Male or female subjects 18 years of age.
•3. Life expectancy of at least 3 months.
•4. Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
•5. Measurable metastatic stage IV disease with at least 1 measurable metastatic lesion following RECIST criteria v 1.1.
•6. Subjects with metastatic colorectal cancer (Stage IV).
•7. Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF and an anti-EGFR (if RAS WT)
•8. Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
•9. Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible. Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study
•10. ECOG Performance Status of 0 or 1(within 14 days prior to the initiation of study treatment)
+9 more criteria

Exclusion Criteria

•1. Prior treatment with regorafenib.
•2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
•3. Pregnant or breast-feeding subjects:
•4. Congestive heart failure = New York Heart Association (NYHA) class 2.
•5. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).
•6. Myocardial infarction less than 6 months before start of study drug.
•7. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
•8. Uncontrolled hypertension. (Systolic blood pressure \> 140 mmHg or diastolic pressure \>90 mmHg despite optimal medical management).
•9. Arterial or venous thromboembolism within 6 months prior to randomization.
•10. Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade 2 dyspnea).
+22 more criteria

Locations (1)

Spanish Cooperative Group for the Treatment of Digestive Tumors

Madrid, Spain

Key Dates

Start Date

July 1, 2016

Primary Completion Date

September 1, 2018

Completion Date

September 1, 2019

Last Updated

March 10, 2020

Enrollment

299

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Regorafenib

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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RECRUITINGPHASE1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Comparing Different Dose Approaches of Induction Treatment of Regorafenib in MCRC

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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