Clinical trial NCT01196741 (phase 2/phase 3, status: completed)
Conditions: ovarian cancer, fallopian tube cancer, primary peritoneal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C57.00, C57.01, C57.02, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02
Drugs: paclitaxel, saracatinib, matched placebo
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1, OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O
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 <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.