Study of AZD8931 in Patients With Advanced Solid Malignancies

Advanced Solid Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637039
• Other study ID #: D0102C00002
• Secondary ID: AZD8931 Study 00
• Status: Completed
• Phase: Phase 1
• First received: March 10, 2008
• Last updated: March 11, 2013
• Start date: February 2008
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2012
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

Drug:
• AZD8931
Tolerability and Pharmacokinetics of AZD8931 in Patients with Advanced Solid Malignancies.

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			Yes
Secondary	To identify the maximum tolerated dose (MTD) of AZD8931 following repeated twice daily administration, by assessment of dose limiting toxicities (DLT)			No
Secondary	To explore the pharmacokinetics (PK) of single doses of AZD8931 in patients with advanced solid malignancies			No
Secondary	To explore the pharmacokinetics (PK) of multiple doses of AZD8931 in patients with advanced solid malignancies			No