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Study of AZD8931 in Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637039
First Posted: March 17, 2008
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Single Group Assignment
Masking: None (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

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

Secondary Outcome Measures:
  • 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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00637039     History of Changes
Other Study ID Numbers: D0102C00002
AZD8931 Study 002
First Submitted: March 10, 2008
First Posted: March 17, 2008
Last Update Posted: March 12, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Neoplasms