A Phase 1, Open-label, Multiple-dose, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD8931 in Patients With Advanced Solid Malignancies
- Cancer which is refractory to standard therapies, or for which no standard therapies
exist. Inclusion is irrespective of stage of disease or extent of prior therapy.
- Histologically or cytologically confirmed solid, malignant tumour.
- Receipt of any of the following treatments within 4 weeks prior to study entry:
chemotherapy (within 6 weeks for nitrosurea or mitomycin C), radiotherapy, hormone
therapy (except for androgen-deprivation therapy for patients with prostate cancer),
immunotherapy and any other anti-cancer therapies.
- Unresolved toxicity (other than stable toxicity) from previous anti-cancer therapy,
- History of documented cardiac failure, angina pectoris requiring antianginal
medication, evidence of transmural infarction on ECG, poorly controlled hypertension
(systolic >180 mmHg or diastolic >100 mmHg), significant valvular disease or history
of high risk dysrrhythmia (such as ventricular fibrillation or ventricular
tachycardia [includes ventricular triplets]).
- Resting ECG with measurable QTc interval of > 460 msec at 2 or more time-points
within a 24-hour time period, or history of prolonged QTc syndrome.
- The presence of any ocular disease or condition that is active or is likely to flare
up during the course of the study or any systemic disease/condition that is affecting
or has affected the eye in the past and may flare up, or the treatment of which may
have an adverse effect on the eye. Eye conditions that are stable and of long
standing, such as scars from trauma, pinguecula, atrophic pterygia etc, should not be
considered as reasons to exclude the patient.