Overview
Regorafenib Phase I Study in Mainland Chinese Patients
Status:
Completed
Completed
Trial end date:
2016-06-01
2016-06-01
Target enrollment:
0
0
Participant gender:
All
All
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 RegorafenibPhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bayer
Criteria
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