Study of AZD8931 in Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637039
First received: March 10, 2008
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Advanced Solid Malignancies
Drug: AZD8931
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To identify the maximum tolerated dose (MTD) of AZD8931 following repeated twice daily administration, by assessment of dose limiting toxicities (DLT) [ Designated as safety issue: No ]
  • To explore the pharmacokinetics (PK) of single doses of AZD8931 in patients with advanced solid malignancies [ Designated as safety issue: No ]
  • To explore the pharmacokinetics (PK) of multiple doses of AZD8931 in patients with advanced solid malignancies [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2008
Study Completion Date: December 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD8931
    Tolerability and Pharmacokinetics of AZD8931 in Patients with Advanced Solid Malignancies.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637039

Locations
Germany
Research Site
Berlin, Germany
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: S. Tjulandin GU Russian Oncology Research Centre
Study Director: Serban Ghiorghiu AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00637039     History of Changes
Other Study ID Numbers: D0102C00002, AZD8931 Study 002
Study First Received: March 10, 2008
Last Updated: March 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation

Keywords provided by AstraZeneca:
Advanced cancer
Solid tumour
Solid malignancies
Neoplasms

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014