Condition category
Cancer
Date applied
12/06/2008
Date assigned
31/07/2008
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Nathan

ORCID ID

Contact details

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

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 measures

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

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

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00664326

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22959186

Publication citations

  1. 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.

Additional files

Editorial Notes

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