Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775.
This is an open-label, non-randomised study designed to provide continued access to AZD1775 for eligible patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of a once daily monotherapy regimen of AZD1775 in patients with advanced solid tumours. All patients who completed 1 of the parent clinical pharmacology studies are eligible for this study after a washout period of at least 4 days (minimum duration defined in the parent study protocol) and meet the eligibility criteria specified in this protocol. Patients who discontinue early from the parent study will be considered by the Sponsor and treating physician on a case-by-case basis. During the study, patients will continue to receive AZD1775 as long as they are benefiting from treatment in the Investigator's opinion and do not meet any other discontinuation criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Patients will receive AZD1775 300 mg orally once daily. Days 1 to 5 and 8 to 12 of a 21 day cycle (ie, 5 days on and 2 days off for Weeks 1 and 2 of a 21-day cycle). All patients must receive a serotonin receptor 3 (5-HT3) antagonist, ondansetron (Zofran) 8 mg orally/IV or granisetron (Kytril) 1 mg orally/IV prior to each dose of AZD1775. Dexamethasone 4 mg orally/IV will be given with each AZD1775 dose at a minimum on the first day of dosing of AZD1775 of every 5 day dosing period, unless contraindicated or not well-tolerated.
Research Site
Bingham Farms, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Lebanon, New Hampshire, United States
Adverse Events, graded by the National Cancer Institute Common Terminology Criteria for Adverse Event's (CTCAE v4.3)
To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours
Time frame: Until 30 days following the final dose of AZD1775
Complete physical examination including performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status criteria.
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours. If new or aggravated physical findings imply deterioration compared with baseline, the finding will be reported as an Adverse Event, unless the findings are unequivocally due to disease progression.
Time frame: Until 30 days following the final dose of AZD1775
Pulse Rate (beats/min)
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Time frame: Until 30 days following the final dose of AZD1775
Blood Pressure (mm Hg)
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Time frame: Until 30 days following the final dose of AZD1775
Body Temperature (°C)
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Time frame: Until 30 days following the final dose of AZD1775
Evaluation of Laboratory Parameters
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours; deterioration of haematology and clinical chemistry laboratory values as compared to baseline will be reported as Adverse Events if they fulfill any of the Serious Adverse Events criteria or are the reason for discontinuation of the study treatment unless clearly due to the progression of disease under study; if deterioration in a laboratory value is associated with clinical signs and symptoms, the sign or symptom will be reported as an AE and the associated laboratory result will be considered as additional information.
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Research Site
Cincinnati, Ohio, United States
Research Site
Providence, Rhode Island, United States
Research Site
Greenville, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
Bordeaux, France
Research Site
Saint-Herblain, France
Research Site
Amsterdam, Netherlands
...and 4 more locations
Time frame: Until 30 days following the final dose of AZD1775