Study of AZD8931 in Patients With Advanced Solid Malignancies

NCT ID: NCT00637039

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-12-31

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

Conditions

Advanced Solid Malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AZD8931

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S. Tjulandin

Role: PRINCIPAL_INVESTIGATOR

GU Russian Oncology Research Centre

Serban Ghiorghiu

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Berlin, , Germany

Research Site

Moscow, , Russia

Research Site

Saint Petersburg, , Russia

Countries

Germany; Russia

References

Tjulandin S, Moiseyenko V, Semiglazov V, Manikhas G, Learoyd M, Saunders A, Stuart M, Keilholz U. Phase I, dose-finding study of AZD8931, an inhibitor of EGFR (erbB1), HER2 (erbB2) and HER3 (erbB3) signaling, in patients with advanced solid tumors. Invest New Drugs. 2014 Feb;32(1):145-53. doi: 10.1007/s10637-013-9963-6. Epub 2013 Apr 16.

Reference Type: DERIVED

PMID: 23589215 (View on PubMed)

Other Identifiers

AZD8931 Study 002

Identifier Type: -

Identifier Source: secondary_id

D0102C00002

Identifier Type: -

Identifier Source: org_study_id