Saracatinib (AZD0530) and docetaxel in metastatic castrate-refactory prostate cancer

ISRCTN	ISRCTN22566729
DOI	https://doi.org/10.1186/ISRCTN22566729
EudraCT/CTIS number	2010-021447-41
Secondary identifying numbers	SAPROCAN VERSION 1.2: 21APR2011. 021447-41

Submission date: 09/08/2011
Registration date: 17/10/2011
Last edited: 19/05/2022

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-docetaxel-and-saracatinib-for-prostate-cancer-spread

Contact information

Dr Rob Jones
Scientific

Cancer Research UK Clinical Trials Unit
The Beatson West of Scotland Cancer Centre, Level 0
(partner in CACTUS - Cancer Clinical Trials Unit Scotland)
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Phone	+44 (0)141 301 7095
Email	robert.jones@glasgow.ac.uk

Study information

Study design	Phase I followed by a phase II randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	SAracatinib (AZD0530) and docetaxel in metastatic castrate-refactory PROstate CANcer: a phase I/randomised phase II study by the NCRI Prostate Clinical Studies Group
Study acronym	SAPROCAN
Study objectives	To provide preliminary evidence regarding whether the addition of saracatinib (AZD0530) to first line docetaxel plus prednisolone will increase progression free survival in patients with metastatic, castrate refractory prostate cancer.
Ethics approval(s)	West of Scotland REC 1, 07/04/2011
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	All patients will receive docetaxel by intravenous (iv) infusion once every 3 weeks for a maximum of 10 cycles with prednisolone 5mg twice daily by mouth from the first day of docetaxel up to at least day 21 of the final dose. Phase I Patients in the phase I component of the study will commence once-daily saracatinib (AZD0530) on day 11 of the first cycle of docetaxel (dose as specified). They will continue until disease progression is confirmed. Phase II Patients in the phase II component of the study will be randomly assigned to receive either saracatinib (AZD0530) once daily by mouth at a dose to be defined in phase I or a matching placebo. This will be taken by mouth starting 7 days prior to the first dose of docetaxel and stopping when disease progression is confirmed.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Docetaxel, prednisolone, saracatinib (AZD0530)
Primary outcome measure	1. Phase I: To establish a safe and tolerable dose for saracatinib (AZD0530) given in combination with with docetaxel and prednisolone 2. Phase II: To establish whether the efficacy of the combination of saracatinib (AZD0530) with docetaxel and prednisolone merits further study in patients with metastatic castrate-refactory prostate cancer (mCRPC)
Secondary outcome measures	1. Phase I: To investigate the effects of saracatinib (AZD0530) on docetaxel pharmacokinetics 2. Phase II: To estimate the effect of saracatinib (AZD0530) on bone pain in patients with mCRPC
Overall study start date	30/09/2011
Completion date	30/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Phase I = 3 -18, Phase II = 140
Key inclusion criteria	1. Male aged 18 or over 2. Histologically or cytologically proven adenocarcinoma of the prostate with previously documented metastases 3. Proven disease progression since last change in therapy defined by at least one of the following: 3.1. Prostate-specific antigen (PSA) progression as defined by the prostate cancer working group (PCWG2) criteria. This must be based on a series of at least three readings at least 7 days apart. The third reading must be greater than or equal to 2ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (ie. the 3 readings do not need to be consecutive). The first of the three readings must have been obtained after commencing the previous systemic therapy, or, in the case of androgen receptor antagonists, after discontinuing. 3.2. Radiographic progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST) for non-bone disease 3.3. The appearance of two or more new lesions on a bone scan 4. Castrate levels of serum testosterone (<1.7nmol/l) 5. Eastern Cooperative Oncology Group performance status (ECOG PS) = 0 or 1 6. Haemoglobin (Hb) >= 10g/dL; platelets >= 100 x 109/L; neutrophils >= 1.5 x109/L 7. Bilirubin <= upper limit of normal (ULN) ; alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 1.5 x ULN 8. Serum Creatinine <=1.5 x ULN or calculated creatinine clearance >= 50 ml/min 9. Able to swallow study drugs 10. Life expectancy > 3 months 11. Provision of written informed consent
Key exclusion criteria	1. Prior cytotoxic chemotherapy for prostate cancer (patients may have received previous or ongoing bisphosphonates, e.g. zoledronate) 2. Prior intolerance of cremaphor 3. Other prior malignancy with estimated >= 30% chance of relapse within 2 years 4. Previously identified brain metastases or spinal cord compression unless treated with full functional recovery 5. Prior radionuclide therapy for prostate cancer 6. Prior radiotherapy to > 30% of bone marrow 7. Administration of investigational agent within 30 days of first dose of study medication 8. Androgen receptor antagonist therapy during 6 weeks prior to initiation of study medication 9. Any evidence of severe or uncontrolled systemic conditions (eg. severe hepatic impairment), or current unstable or uncompensated cardiac condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol 10. Any evidence of pneumonitis or other interstitial lung disease (bilateral, diffuse, parenchymal lung disease) or current unstable or uncompensated respiratory condition 11. Resting electrocardiogram (ECG) with measurable QTc interval of > 480 msec at 2 or more time points within a 24 hour period 12. Patients with known immunodeficiency syndrome 13. Unable to discontinue any medication or herbal supplement that may significantly modulate CYP3A4 activity or which is significantly metabolised by CYP3A4. Such drugs must have been discontinued for an appropriate period prior to starting AZD0530. 14. Unresolved toxicity ≥ Common Terminology Criteria (CTC) grade 2 (except alopecia) from previous anti-cancer therapy 15. Patients with a partner of child-bearing potential who is not using a highly effective method of contraception, who are unwilling to use condoms during the study and for 30 days after the last dose of study drug 16. Known hypersensitivity to AZD0530 (saracatinib, its excipients, or drugs in its class 17. Known malabsorption syndrome
Date of first enrolment	30/09/2011
Date of final enrolment	30/04/2015

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Cancer Research UK Clinical Trials Unit

Glagow
G12 0YN
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre

Research and Development Central Office
The Tennent Institute, 1st Floor
Western Infirmary General
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom

Website	http://www.nhsggc.org.uk/
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Industry

AstraZeneca
Government organisation / For-profit companies (industry)

Alternative name(s): AstraZeneca PLC, Pearl Therapeutics
Location: United Kingdom

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		21/08/2020	19/05/2022	No	No

Editorial Notes

19/05/2022: EU Clinical Trials Register results added.
24/07/2020: Added EudraCT number.
06/07/2017: No publications found, verifying study status with principal investigator.