Continuous Dosing of BAY73-4506 in Patients With Advanced Malignancies

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasm

Treatments: Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg; Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg; Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg; Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg; Drug: HCC Child-Pugh A expansion cohort: Regorafenib 100 mg; Drug: NSCLC expansion cohort: Regorafenib 100 mg; Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg; Drug: HCC Child-Pugh B expansion cohort: Regorafenib 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01117623

11651

Details and patient eligibility

About

Continuous dosing of BAY73-4506 in patients with advanced cancer

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years

• Patients with advanced, histologically or cytologically confirmed solid tumors, malignant lymphomas, or multiple myeloma refractory to any standard therapy

• Radiographical, hematological or clinically evaluable tumor

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

• Life expectancy of at least 12 weeks

• Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements:

  • Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)

• Signed informed consent must be obtained prior to any study specific procedures

Exclusion criteria

• History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
• History of HIV infection or chronic hepatitis B or C
• Active clinically serious infections (> Grade 2 NCI Common Terminology Criteria for Adverse Events v3.0)
• Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Patients with brain metastases must not be undergoing acute steroid therapy or steroid taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
• Substance abuse, medical, psychological or social conditions that may interfere with the patient178s participation in the study or evaluation of the study results
• Radiotherapy to the target lesions within 3 weeks prior to Day 1, Cycle 1 (first dose of study drug). (Palliative radiotherapy will be allowed). Radiotherapy to the target lesions during study will be regarded as progressive disease
• Previous or concurrent cancer which is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis and T1] or any cancer curatively treated > 3 years prior to study entry.

Trial design

86 participants in 8 patient groups

Arm 1

Experimental group

Treatment:

Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg

Arm 2

Experimental group

Treatment:

Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg

Arm 3

Experimental group

Treatment:

Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg

Arm 4

Experimental group

Treatment:

Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg

Arm 5

Experimental group

Treatment:

Drug: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg

Arm 6

Experimental group

Treatment:

Drug: HCC Child-Pugh A expansion cohort: Regorafenib 100 mg

Arm 7

Experimental group

Treatment:

Drug: HCC Child-Pugh B expansion cohort: Regorafenib 100 mg

Arm 8

Experimental group

Treatment:

Drug: NSCLC expansion cohort: Regorafenib 100 mg