A phase II uncontrolled study of BAY 73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC)

ISRCTN	ISRCTN69484574
DOI	https://doi.org/10.1186/ISRCTN69484574
ClinicalTrials.gov number	NCT00664326
Secondary identifying numbers	11726

Submission date: 12/06/2008
Registration date: 31/07/2008
Last edited: 22/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Nathan
Scientific

Department of Medical Oncology
The Clock Tower
Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom

Study information

Study design	Interventional single-treatment open-label phase II trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A phase II uncontrolled study of BAY 73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC)
Study acronym	DAST
Study objectives	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(s)	Brighton East Research Ethics Committee, 06/06/2008, ref: 08/H1107/58
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	30/04/2008
Completion date	30/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	49
Key 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
Key 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
Date of first enrolment	30/04/2008
Date of final enrolment	30/11/2011

Locations

Countries of recruitment

England
Finland
France
Germany
Poland
United Kingdom
United States of America

Study participating centre

Mount Vernon Hospital

Northwood
HA6 2RN
United Kingdom

Sponsor information

Bayer Healthcare Pharmaceuticals Inc. (USA)
Industry

400 Morgan Lane
West Haven
CT 06516
United States of America

Phone	+1 800 468 0894
Email	clinical-trials-contact@bayerhealthcare.com
"ROR"	https://ror.org/04hmn8g73

Funders

Funder type

Industry

Bayer Corporation
Private sector organisation / For-profit companies (industry)

Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	01/10/2012		Yes	No

Editorial Notes

22/03/2016: added link to results - basic reporting.