Regorafenib Phase I Study in Mainland Chinese Patients

Oncology Clinical Trial

Official title:

Uncontrolled, Open-label, Non-randomized, Phase I Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Regorafenib in Chinese Patients (China Mainland) With Advanced, Refractory Solid Tumors)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398513
• Other study ID #: 15823
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2015
• Last updated: July 29, 2016
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: China Food and Drug adminstration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to define the pharmacokinetic of Regorafenib administered orally as a single agent in Chinese patients with advance solid tumors.

The second objective include the evaluation of safety, tolerability, and efficacy of Chinese patents treated with Regorafenib

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and be willing to sign the written informed consent

• Patients with histologically or cytologically confirmed,refractory,locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom the specific clinical indications for which Regorafenib is approved elsewhere in the world is considered an appropriate treatment option.

• Male or female Chinese patients living in China mainland >= 18 years

• Patients must have measurable or non-measurable disease according to RECIST, version 1.1

• Eastern Cooperative Oncology Group performance status (ECOG-PS 0 - 1)

• Body mass index (BMI) between 18 and 33 kg/m2 inclusive

• Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:

• Platelet count >= 100,000/cubic millimeters (mm3), hemoglobin (Hb) >= 9 g/dl, leukocyte count > 3,000/mm3, absolute neutrophil count (ANC) >=1,500/mm3. Transfusion to meet the inclusion criteria will not be allowed.

• Total bilirubin <= 1.5 x the upper limit of normal (ULN).

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 x ULN (<= 5 x ULN for patients with liver involvement of their cancer)

• Alkaline phosphatase limit <= 2.5 x ULN (<= 5 x ULN for patients whose cancer involves their liver and/or bone)

• Lipase <= 1.5 x ULN

• Serum creatinine <= 1.5 times ULN and estimated creatinine clearance (CLcr) >= 30 mL/min according to the Cockroft-Gault formula

• International normalized ratio (INR) <= 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) <= 1.5 x ULN. Patients being treated with anticoagulant, e.g. warfarin or heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.

• Life expectancy of at least 3 months.

• Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment.

Exclusion Criteria:

• Prior treatment with Regorafenib

• Patients unable to swallow and retain oral medications

• Any other malignant disease treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1)

• Symptomatic metastatic brain or meningeal tumors if the patient is < 6 months from definitive therapy, has evidence of tumor growth on an imaging study within 4 weeks prior to study entry and is on dexamethasone and not clinically stable with respect to the tumor at the time of study entry.

• Major surgical procedure, or significant traumatic injury within 28 days before start of study medication

• History of organ allograft

• Non-healing wound, ulcer, or bone fracture

• Uncontrolled hypertension (systolic blood pressure >150 millimeter of mercury (mmHg) or diastolic blood pressure >90 mmHg despite optimal medical management)

• Persistent proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (>=Grade 3, NCI-CTCAE v 4.03).

• History of cardiac disease: congestive heart failure (CHF) >=NYHA (New York Heart Association) Class II. Active coronary artery disease unstable angina (angina symptoms at rest) or new-onset angina (within last 3 months) or myocardial infarction (MI) within past 6 months

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oncology

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
Regorafenib 160 mg per oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum drug concentration in plasma)		Cycle 0 day 1, 0?0.5?1?2?3?4?6?8?12?24?36?48?72?96 hours	No
Primary	AUC(0-24) (AUC from time 0 h to time 24 h post-administration)		Cycle 0 day1, 0?0.5?1?2?3?4?6?8?12?24 hours	No
Primary	AUC(0-tlast) (AUC from time zero to the last data point>LLOQ)		Cycle0 day 1, 0?0.5?1?2?3?4?6?8?12?24?36?48?72?96 hours	No
Primary	Cmax.ss (Cmax at steady-state during a dosage interval)		Cycle 1 day 21, 0,0.5,1,2,3,4,6,8,12,24,36,48,72,96 hours	No
Primary	AUCt.ss (AUC for the dosing interval at steady-state)		cycle 1 day 21 0,0.5,1,2,3,4,6,8,12,24 hours	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 30 days	Yes
Secondary	Tumor Response base don RECIST 1.1 criteria		Up to 30 days	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.