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

AstraZeneca1 site in 1 country41 target enrollmentFebruary 2008

ConditionsAdvanced Solid Malignancies

DrugsAZD8931

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Malignancies
Sponsor: AstraZeneca
Enrollment: 41
Locations: 1
Primary Endpoint: Explore the safety and tolerability of multiple ascending doses (MAD) of AZD8931 in patients with advanced solid malignancies, by assessment of AEs, lab findings, physical examinations, vital signs, cardiac monitoring and ophthalmological examinations
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to explore the safety and tolerability of multiple ascending doses (MAD) of AZD8931 in patients with advanced solid malignancies

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

December 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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, except alopecia.
•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.

Outcomes

Primary Outcomes

Explore the safety and tolerability of multiple ascending doses (MAD) of AZD8931 in patients with advanced solid malignancies, by assessment of AEs, lab findings, physical examinations, vital signs, cardiac monitoring and ophthalmological examinations

Secondary Outcomes

To identify the maximum tolerated dose (MTD) of AZD8931 following repeated twice daily administration, by assessment of dose limiting toxicities (DLT)
To explore the pharmacokinetics (PK) of single doses of AZD8931 in patients with advanced solid malignancies
To explore the pharmacokinetics (PK) of multiple doses of AZD8931 in patients with advanced solid malignancies