Continuous Dosing of BAY73-4506 in Patients With Advanced Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01117623
First received: February 11, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

Continuous dosing of BAY73-4506 in patients with advanced cancer


Condition Intervention Phase
Neoplasm
Drug: Regorafenib (BAY73-4506)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse Events Collection according to National Cancer Institute Common Terminology Criteria for Adverse Events ( NCI-CTCAE) [ Time Frame: Depending on treatment duration for individual patients ( expected 3 months to 2 years) ] [ Designated as safety issue: Yes ]
  • Determination of Maximum Tolerated Dose (MTD) and recommended Phase II dose [ Time Frame: Depending on treatment duration for individual patients ( expected 3 months to 2 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • BAY 73-4506 plasma and urine concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Tumor measurements according to RECIST (Response Evaluation Criteria in Solid Tumors) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Biomarkers VEGF, sVEGFR-2 plasma levels [ Time Frame: 3 months to 1 year ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: February 2007
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Regorafenib (BAY73-4506)
Single agent BAY 73-4506 continuously administered dose escalation starting dose 20 mg once daily, maximum dose 140 mg once daily
Experimental: Arm 2 Drug: Regorafenib (BAY73-4506)
Expansion cohort at 100 mg once daily dose of BAY 73-4506 enrolling Non Small Cell Lung Cancer and Hepatocellular Carcinoma patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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) > 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117623

Locations
United States, California
Los Angeles, California, United States, 90095
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78229-3307
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01117623     History of Changes
Other Study ID Numbers: 11651
Study First Received: February 11, 2010
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Oncology patients with advanced disease
BAY73-4506

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014