Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00664326
Protocol/serial number
11726
Study information
Scientific title
A phase II uncontrolled study of BAY 73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC)
Acronym
DAST
Study hypothesis
Primary hypothesis:
Response rate of patients with advanced renal cell cancer (RCC) to BAY 73-4506.
Secondary hypothesis:
The evaluation of pharmacokinetic and biomarker data.
Ethics approval
Brighton East Research Ethics Committee, 06/06/2008, ref: 08/H1107/58
Study design
Interventional single-treatment open-label phase II trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Unresectable and/or metastatic renal cell cancer
Intervention
Patients will be treated with BAY 73-4506 160 mg orally (PO) once daily (OD) for three weeks of every four week cycle (i.e. three weeks on, one week off). Patients will continue treatment with BAY 73-4506 until disease progression, intolerable toxicity or patient refusal to continue with the study or at the investigator's decision to remove the patient from the study.
Intervention type
Drug
Phase
Phase II
Drug names
BAY 73-4506
Primary outcome measure
Response rate of patients with advanced RCC to BAY 73-4506.
Secondary outcome measures
1. Survival
2. Progression-free survival
3. Time to progression
4. Safety (adverse events [AEs], vitals, labs, electrocardiogram [ECG])
5. Duration of stable disease
6. Pharmacokinetic
7. Pharmacodynamic
8. Duration of response
Overall trial start date
30/04/2008
Overall trial end date
30/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Greater than or equal to 18 years, either sex
2. Unresectable and/or metastatic clear cell renal cell cancer
3. Previously untreated disease
4. Measurable lesion(s) by computed tomography (CT) scan/magnetic resonance imaging (MRI)
5. Intermediate or low Motzer score
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate bone marrow, renal and hepatic function as assessed by specific laboratory tests
8. Life expectancy of at least 12 weeks
9. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
49
Participant exclusion criteria
1. Previous/concurrent cancer
2. Previous systemic treatment of RCC
3. Cardiac arrhythmias requiring anti-arrythmics
4. History of cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) class 2
5. Uncontrolled hypertension despite optimal medical management
6. Cardiac ventricular arrhythmias requiring anti-arrhythimics
7. Active clinically serious infections
8. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
9. Know history of symptomatic metastatic brain or meningeal tumours
10. Seizure disorders requiring medication
11. History of organ allograft
12. History or evidence of bleeding diathesis
13. Serious non-healing wound, ulcer or bone fracture
14. Patients undergoing renal dialysis
15. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
16. Known or suspected allergy to the investigational drug or any agent given in association with the trial
17. Any condition which is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
18. Pregnant or breast-feeding patients
19. Investigational drug therapy outside of the trial within 4 weeks of study entry
20. Prior exposure to the drug
21. Radiotherapy during study or within 3 weeks of start of study drug
22. Major surgery, open biopsy or significant traumatic injury within 4 weeks of start of study
23. Autologous bone marrow transplant or stem cell rescue within 4 months of study
24. Patients unable to swallow oral medications
25. Any malabsorption condition
Recruitment start date
30/04/2008
Recruitment end date
30/11/2011
Locations
Countries of recruitment
Finland, France, Germany, Poland, United Kingdom, United States of America
Trial participating centre
Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom
Sponsor information
Organisation
Bayer Healthcare Pharmaceuticals Inc. (USA)
Sponsor details
400 Morgan Lane
West Haven
CT 06516
United States of America
+1 800 468 0894
clinical-trials-contact@bayerhealthcare.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bayer Corporation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
See https://clinicaltrials.gov/ct2/show/results/NCT00664326
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22959186
Publication citations
-
Results
Eisen T, Joensuu H, Nathan PD, Harper PG, Wojtukiewicz MZ, Nicholson S, Bahl A, Tomczak P, Pyrhonen S, Fife K, Bono P, Boxall J, Wagner A, Jeffers M, Lin T, Quinn DI, Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial., Lancet Oncol., 2012, 13, 10, 1055-1062, doi: 10.1016/S1470-2045(12)70364-9.