Status:
COMPLETED
Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer
Lead Sponsor:
University College, London
Collaborating Sponsors:
AstraZeneca
Cancer Research UK
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to investigate whether the addition of the Src inhibitor saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus placebo, in patients w...
Detailed Description
A multicentre, randomised, double-blind, placebo-controlled Phase II trial will be conducted. The overall aim of the trial is to investigate whether the addition of saracatinib to weekly paclitaxel im...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Confirmed relapsed ovarian, fallopian tube or primary peritoneal cancer AND relapse within the platinum-resistant (progression must not be based on Cancer Antigen 125 (CA125) alone) time-frame, i.e. have progressed within 6 months of platinum therapy.
- Patients need not have received prior taxane; if patients have received prior taxane, the interval since treatment must be known. Patients will be stratified as \<6 months or 6+ months taxane interval/no prior taxane.
- Patients will generally have received at least 2 lines of prior chemotherapy, but may enter if they have relapsed within 6 months of first line therapy. Patients may have received prior liposomal doxorubicin, although this is NOT a requirement. The treatment immediately prior to study entry need not be platinum-based.
- Measurable or evaluable disease (if not measurable by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 criteria, patients must be evaluable by Gynecologic Cancer InterGroup (GCIG) CA125 criteria).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
- Adequate haematological and biochemical function.
- Exclusion criteria
- Prior administration of weekly paclitaxel.
- Tumours of malignant mixed mesodermal (MMMT) or mucinous subtypes, or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours).
- Unresolved bowel obstruction.
- Chemotherapy within the preceding 3 weeks.
- Radiotherapy within the preceding 3 weeks.
- Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.
- Known leptomeningeal involvement or intracranial disease.
- Evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease).
- Resting ECG with measurable QTc interval of \>480 msec at 2 or more time points within a 24 hour period.
- Pregnant or lactating females.
- Fertile women of childbearing potential not willing to use highly effective contraception for the duration of trial treatment and for at least 6 months after the last administration of saracatinib +/- paclitaxel.
- Inability or unwillingness to give informed consent.
- Ongoing active infection or a documented history of HIV infection, Hepatitis B or C.
- Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
- Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease.
- Use of immunosuppressive therapy or corticosteroids taken within the 4 weeks prior to study entry and during the treatment period.
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01196741
Start Date
March 1 2011
End Date
January 1 2014
Last Update
May 5 2015
Active Locations (12)
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1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, BC2 0QQ
2
St Bartholomew's Hospital
London, Greater London, United Kingdom, EC1A 7BE
3
University College London Hospital
London, Greater London, United Kingdom, NW1 2PG
4
Guy's Hospital
London, Greater London, United Kingdom, SE1 9RT