Phase 3
N=107
Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer
Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01196741 ↗Enrolled (actual)
107
Serious AEs
55.8%
Results posted
May 2015
Primary outcome: Primary: 6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria) — 29; 34 percentage of participants — p=0.57
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paclitaxel (Drug); Saracatinib (Drug); Matched placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University College, London
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria) |
29; 34 | 0.57 |
| SECONDARY Overall Survival |
10.1; 12.3 | 0.81 |
| SECONDARY Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria |
29; 43 | — |
| SECONDARY Median Duration of Response |
— | — |
| SECONDARY Quality of Life: Trial Outcome Index (TOI) Based on FACT-O |
66.89; 73.10 | 0.0476 sig |
| SECONDARY Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria |
— | — |
| SECONDARY Median PFS |
4.7; 5.3 | 0.99 |
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 with relapsed platinum-resistant ovarian cancer. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01196741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.