Study of AZD8931 in Patients With Advanced Solid Malignancies
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637039
First received: March 10, 2008
Last updated: March 11, 2013
Last verified: March 2013
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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 May 23, 2013