Phase Ib Study AZD1775 in Combination With Carboplatin and Paclitaxel in Adult Asian Patients With Solid Tumours
This trial is enrolling by invitation only.
|Condition||advanced solid tumours|
|Treatments||azd1775, paclitaxel, carboplatin|
|Start date||January 2015|
|End date||December 2016|
|Trial size||20 participants|
|Trial identifier||NCT02341456, D6011C00003|
This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in monotherapy and in combination with carboplatin and paclitaxel to Asian patients with advanced solid tumours.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Liverpool, Australia||Research Site||enrolling by invitation|
|Melbourne, Australia||Research Site||enrolling by invitation|
|Kashiwa-shi, Japan||Research Site||enrolling by invitation|
|Sapporo-shi, Japan||Research Site||enrolling by invitation|
|Seoul, Korea, Republic of||Research Site||enrolling by invitation|
|Intervention model||parallel assignment|
Safety and tolerability of AZD1775 in terms of AEs, labs, vitals, ECGs and conc. med use.
time frame: through end of Cycle 6 + 28 day follow-up period
Recommended dose of AZD1775
time frame: through end of Cycle 1
PK profile of AZD1775 after single dosing and at steady state after multiple dosing in combination with carboplatin and paclitaxel
time frame: cycle 0 day 1 (monotherapy) and cycle 1 days 1 and 3 (combination)
PK profile of paclitaxel in combination with carboplatin and AZD1775
time frame: through Cycle 1 Day 1
PK profile of carboplatin in combination with paclitaxel and AZD1775
time frame: through Cycle 1 Day 1
Preliminary assessment of the anti-tumour activity of AZD1775
time frame: up to 21 months (through end of Cycle 6 from baseline through to objective disease progression or death)
All participants from 18 years up to 100 years old.
- Histological or cytological confirmation of a locally advanced or metastatic solid tumour, excluding lymphoma, that failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
- At least 1 measureable lesion that can be accurately assessed at baseline by computerised tomography (CT) or magnetic resonance imaging (MRI) for solid tumours assessed using RECIST v1.1.
- World Health Organisation performance status 0 to 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of ≥12 weeks.
- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days (if investigational agent does not have well characterised PK profile) or 5 × half-lives of the first dose of study treatment
- Patient has had prescription or non-prescription drugs or other products (ie, grapefruit juice) known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 2 weeks before Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. Co-administration of aprepitant during this study is prohibited.
- AZD1775 is an inhibitor of breast cancer resistance protein (BCRP). The use of statins including Atorvastatin which are substrates for BCRP are therefore prohibited and patients should be moved on to non-BCRP alternatives.
|Official title||A Phase Ib, Dose Finding Study Evaluating AZD1775 in Monotherapy, in Combination With Carboplatin and Paclitaxel, and in Combination With Only Carboplatin in Adult Asian Patients With Advanced Solid Tumours|
|Principal investigator||Dr. Paul De Souza, MD|
|Description||This is a phase Ib, open label, multicentre study of AZD1775 administered orally in monotherapy and in combination with carboplatin and paclitaxel in Asian patients with advanced solid tumours. The study design allows escalation or de-escalation of AZD1775 in combination with carboplatin and paclitaxel with intensive safety monitoring to ensure the safety of the patients. Approximately 12 evaluable patients will be enrolled in the dose-finding portion of this study. The total number of patients will depend upon the number of combination dose level evaluations necessary to define the recommended dose for further clinical evaluation. The proposed combination doses are : Dose level-1; Dose level 1; Dose level 2 (if Dose Level 1 tolerated). All combination doses other than Combination Dose level 1 may be subject to change by the SRC in light of emerging data. At least 3 and up to 6 evaluable patients will be required for each dose finding cohort. Once the recommended dose for further clinical evaluation is established, additional 3 to 6 patients may be enrolled to the cohort where the recommended dose has been defined to further characterise the safety, tolerability, pharmacokinetics, and efficacy profiles of AZD1775 in combination with paclitaxel and carboplatin. If this dose is subsequently found to be non-tolerated, alternative doses and/or schedules may be explored. This will be determined by the SRC.|
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