Study of AZD8931 in Patients With Advanced Solid Malignancies

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00637039
• Date of registration: 10/03/2008
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Study of AZD8931 in Patients With Advanced Solid Malignancies
• Scientific 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
• Date of first enrolment: February 2008
• Target sample size: 41
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00637039
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany, Russian Federation

Contacts

• Name: S. Tjulandin
• Affiliation: GU Russian Oncology Research Centre

• Name: Serban Ghiorghiu
• Affiliation: AstraZeneca

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Solid Malignancies

Intervention(s)

Drug: AZD8931

Primary Outcome(s)

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 [Time Frame: Yes]

Secondary Outcome(s)

To explore the pharmacokinetics (PK) of multiple doses of AZD8931 in patients with advanced solid malignancies [Time Frame: No]

To explore the pharmacokinetics (PK) of single doses of AZD8931 in patients with advanced solid malignancies [Time Frame: No]

To identify the maximum tolerated dose (MTD) of AZD8931 following repeated twice daily administration, by assessment of dose limiting toxicities (DLT) [Time Frame: No]

Secondary ID(s)

AZD8931 Study 002

D0102C00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors