Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)

Summary

The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from regorafenib treatment, as well as to assess treatment continuation of regorafenib.

Conditions

• Rectal Cancer

Interventions

OTHER

General condition

Eastern Cooperative Oncology Group (ECOG) performance status (PS), height and body weight

OTHER

Blood pressure

systolic blood pressure (SBP)/diastolic blood pressure (DBP)

OTHER

Patient Reported Outcome

Incidence of fatigue or malaise (All grade of CTCAE ver. 4), anorexia, Brief fatigue inventory (BFI), FACT-C.

OTHER

Clinical findings

* Blood and lymphatic system disorders: febrile neutropenia * Gastrointestinal disorders: constipation, diarrhea, oral mucositis, nausea, and vomiting * General disorders and administration site conditions: fatigue and malaise * Immune system disorders: allergic reaction * Metabolism and nutrition disorders: anorexia * Nervous system disorders: dysgeusia and peripheral sensory neuropathy * Respiratory, thoracic and mediastinal disorders: hoarseness (change of voice) * Skin and subcutaneous tissue disorders: alopecia, skin hyperpigmentation, urticaria, and palmar-plantar erythrodysesthesia syndrome * Vascular disorders: hypertension * Symptomatic pancreatitis

OTHER

Hematology/blood chemistry

White blood cell count, absolute neutrophil count (stab + segmented), hemoglobin, platelet count, albumin, total bilirubin, aspartate aminotransferase(AST) (GOT), alanine aminotransferase (ALT) (GPT), serum creatinine, Na, K

OTHER

Coagulation and fibrinolysis system

international normalized ratio (INR)

OTHER

Urinalysis

Proteinuria (qualitative)

OTHER

Medication check

Medicine taking situation (regorafenib, dexamethasone and placebo) determined by subject's diary at every courses

OTHER

Adverse event

CTCAE ver.4.0

OTHER

Thyroid function test

Thyroid-stimulating hormone (TSH), T4, and T3

OTHER

Contrast-enhanced torso CT

It is recommended that CT images should be taken every 4 weeks (if possible) or at least every 8 weeks (allowable time window: ± 2 weeks), with the treatment phase taken into consideration.

OTHER

Brain MRI

If any symptom of brain metastasis is suspected

DRUG

Dexamethasone

Capsule filled with dexamethasone and lactose

DRUG

Regorafenib

Film-coating tablet contains 40 mg of regorafenib

DRUG

Placebo

Capsule filled with lactose

DRUG

Proton pump inhibitor

PPIs (omeprazole, lansoprazole, etc, as not specified) for prevention of peptic ulcer

Sponsors & Collaborators

• Clinical Research Support Center Kyush

  lead OTHER

Principal Investigators

• Yasunori Emi, MD, PhD · Saiseikai Fukuoka General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-09-30

Completion

2016-09-30

Countries

• Japan

Study Locations