NCT00637039

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

March 10, 2008

Last Update Submit

March 11, 2013

Conditions

Advanced Solid Malignancies

Keywords

Advanced cancerSolid tumourSolid malignanciesNeoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 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

Interventions

AZD8931DRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed solid, malignant tumour.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Berlin, Germany

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Related Publications (1)

  • 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.

    PMID: 23589215DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

AZD 8931

Study Officials

  • S. Tjulandin

    GU Russian Oncology Research Centre

    PRINCIPAL INVESTIGATOR

  • Serban Ghiorghiu

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 17, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2009

Study Completion

December 1, 2012

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

RU(2)DE(1)