SAracatinib (AZD0530) and docetaxel in metastatic castrate-refactory PROstate CANcer | Not Recruiting
SAracatinib (AZD0530) and docetaxel in metastatic castrate-refactory PROstate CANcer
SAPROCAN
Trial Source

Health Conditions
  • Prostate Cancer
Not Recruiting
Recruitment Status
ISRCTN22566729
Primary Trial ID Number
Summary
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 refactory prostate cancer
Primary Outcome Measures
  • 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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
West of Scotland REC 1, 7 April 2011
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
140
Participant 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
Participant 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
Interventions
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.
Design Details
Sorry, this information is not available
Study Design
Phase I followed by a phase II randomised placebo controlled trial
Results Reporting
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Acronym
SAPROCAN
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
Secondary Trial Identifying Number
SAPROCAN VERSION 1.2: 21APR2011. 021447-41
Website
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Study Funded By
Astrazeneca UK Ltd (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
NHS Greater Glasgow and Clyde (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

30 Sep 2011

Recruitment End Date

30 Apr 2015

Trial End Date

30 Apr 2015

Date added to Registry

17 Oct 2011

Last Updated

14 Feb 2012