March 10, 2008 |
June 24, 2009 |
February 2008 |
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 ] |
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 ] |
Complete list of historical versions of study NCT00637039 on ClinicalTrials.gov Archive Site |
- 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 ]
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- To identify the MTD of AZD8931 following repeated twice daily administration, by assessment of DLT. [ Designated as safety issue: No ]
- To explore the PK of single doses of AZD8931 in patients with advanced solid malignancies. [ Designated as safety issue: No ]
- To explore the PK of multiple doses of AZD8931 in patients with advanced solid malignancies. [ Designated as safety issue: No ]
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Study of AZD8931 in Patients With Advanced Solid Malignancies |
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 |
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 |
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Phase I |
Interventional |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Advanced Solid Malignancies |
Drug: AZD8931 |
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Active, not recruiting |
30 |
June 2009 |
June 2009 (final data collection date for primary outcome measure) |
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.
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Both |
18 Years and older |
No |
Contact information is only displayed when the study is recruiting subjects |
Germany, Russian Federation |
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NCT00637039 |
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D0102C00002, AZD8931 Study 002 |
AstraZeneca |
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Principal Investigator: |
S. Tjulandin |
GU Russian Oncology Research Centre |
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Study Director: |
Mary Stuart |
AstraZeneca |
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AstraZeneca |
June 2009 |