Study Completed

Neoplasm

Bayer Identifier:

11651

ClinicalTrials.gov Identifier:

NCT01117623

EudraCT Number:

Not Available

EU CT Number:

Not Available

Continuous dosing of BAY73-4506 in patients with advanced malignancies

Trial purpose

Continuous dosing of BAY73-4506 in patients with advanced cancer

Key Participants Requirements

Sex

Both

Age

18 - N/A

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 summary

Enrollment Goal

Trial Dates

February 2007 - November 2013

Phase

Phase 1

Could I Receive a placebo

Products

Stivarga (Regorafenib, BAY73-4506)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Institute for Drug Development	San Antonio, 78229, United States
Completed	South Texas Accelerated Research Therapeutics, LLC	San Antonio, 78229-3307, United States
Completed	University of California, Los Angeles	Los Angeles, 90095, United States
Completed	University of Texas MD Anderson Cancer Center	Houston, 77030, United States
Completed	University of Colorado Hospital	Aurora, 80045, United States

Primary Outcome

Maximum Tolerated Dose (MTD)
Time Frame:
Within first 4 weeks of treatment
Safety Issue:
Yes
Maximum observed plasma concentration after single dose administration (Cmax)
Time Frame:
Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose
Safety Issue:
No
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC)
Time Frame:
Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose
Safety Issue:
No
Cmax at steady state during a dosing interval (Cmax,ss)
Time Frame:
Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.
Safety Issue:
No
AUC from time 0 to 24 hours at steady state(AUC(0-24),ss)
Time Frame:
Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.
Safety Issue:
No

Secondary Outcome

AUC from time 0 to the last data point > lower limit of quantification (LLOQ) (AUC(0-tlast))
Time Frame:
Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose
Safety Issue:
No
Area under the concentration vs. time curve from zero to infinity after single (first) dose divided by dose (AUC/D)
Time Frame:
Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose
Safety Issue:
No
Maximum observed plasma concentration after single dose administration divided by dose (Cmax/D)
Time Frame:
Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose
Safety Issue:
No
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame:
Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.
Safety Issue:
No
Half-life associated with the terminal slope (T1/2)
Time Frame:
Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.
Safety Issue:
No
Cmax at steady state during a dosing interval divided by dose (Cmax,ss/D)
Time Frame:
Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose
Safety Issue:
No
AUC from time 0 to 24 hours at steady state divided by dose (AUC(0-24)ss/D)
Time Frame:
Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose
Safety Issue:
No
Time to Reach Maximum Observed Plasma Concentration at steady state (Tmax,ss)
Time Frame:
Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose
Safety Issue:
No
Ratio of Cmax,ss/Cmax (RACmax)
Time Frame:
Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose
Safety Issue:
No
Ratio of Cmin,ss/Cmin (RACmin)
Time Frame:
Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose
Safety Issue:
No
Ratio of AUCt,ss/AUCt (RAAUC)
AUCt,ss is AUC during any dose interval at steady state
Time Frame:
Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose
Safety Issue:
No
Ratio of AUCt,ss/AUC (RLIN)
Time Frame:
Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose
Safety Issue:
No
Biomarker vascular endothelial growth factor (VEGF) plasma levels
Time Frame:
No data obtained
Safety Issue:
No
Biomarker soluble vascular endothelial growth factor receptor 2 (sCEGFR-2) plasma levels
Time Frame:
No data obtained
Safety Issue:
No

Trial design

Open label, Phase I study to determine the safety, tolerability, maximum tolerated dose, pharmacokinetics, and biomarker status of BAY73-4506 in patients with advanced malignancies

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Non-randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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