Solid Tumors
Conditions
Keywords
Continued access, safety assessments
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Quintiles, Inc.
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
For inclusion in this study, patients must fulfil the following criteria: * Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures. * Female or male aged ≥18 years. * Has completed 1 of the parent AZD1775 clinical pharmacology studies (ie, D6014C00002, D6014C00003, D6014C00004, D6014C00005, or D6014C00006) and in the Investigator's opinion will continue to benefit from treatment with AZD1775. Patients who discontinue early from the parent study will be considered by the Sponsor and treating physician on a case-by-case basis. * Any prior radiation must have been completed at least 7 days prior to the start of study treatment, and patients must have recovered from any acute effects prior to the start of study treatment. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1. * Baseline laboratory values within 7 days of study treatment initiation in the CA study: * Absolute neutrophil count (ANC) ≥1500/μL. * Haemoglobin ≥9 g/dL. * Platelets ≥100,000/μL. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if known hepatic metastases. * Serum bilirubin within normal limits or ≤1.5 x ULN in patients with liver metastases; or total bilirubin ≤3.0 x ULN with direct bilirubin within normal limits in patients with well documented Gilbert's Syndrome. * Serum creatinine ≤1.5 x ULN, or measured creatinine clearance (CrCl) calculated by Cockcroft-Gault method ≥45 mL/min (confirmation of creatinine clearance is only required when creatinine is \>1.5 x ULN) CrCl (glomerular filtration rate) = (140-age) x (weight/kg) x Fa (72 x serum creatinine mg/dL) where F = 0.85 for females and F = 1 for males. * Female patients who are of non-childbearing potential and fertile women of childbearing potential (WoCBP) who agree to use adequate contraceptive measures that are in place during screening (or consent), for the duration of the study, and for 1 month after treatment stops; who are not breastfeeding; and who have a negative serum or urine pregnancy test prior to the start of study treatment. * Male patients must be willing to use barrier contraception (ie, condoms) for the duration of the study and for 3 months after study treatment discontinuation. * Willingness and ability to comply with the study and the follow-up procedures.
Exclusion criteria
Patients must not enrol in this study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events, graded by the National Cancer Institute Common Terminology Criteria for Adverse Event's (CTCAE v4.3) | Until 30 days following the final dose of AZD1775 | To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours |
| Complete physical examination including performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status criteria. | Until 30 days following the final dose of AZD1775 | 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. |
| Pulse Rate (beats/min) | Until 30 days following the final dose of AZD1775 | To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours. |
| Blood Pressure (mm Hg) | Until 30 days following the final dose of AZD1775 | To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours. |
| Body Temperature (°C) | Until 30 days following the final dose of AZD1775 | To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours. |
| Evaluation of Laboratory Parameters | Until 30 days following the final dose of AZD1775 | 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. |
Countries
France, Netherlands, United Kingdom, United States
Outcome results
None listed