Conditions: Solid Tumours
Keywords: oncology, cancer, tumour, neoplasm, anticancer drug, pharmacokinetics, olaparib, anastrozole, tamoxifen, letrozole,
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 79
Healthy volunteers: no

Brief summary:
This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.

Detailed description:

Arms:
arm 1: Olaparib-alone Steady state PK, Tamoxifen-alone steady state PK, Combined olaparib and Tamoxifen steady state PK. arm 2: Olaparib-alone Steady state PK, Anastrozole-alone steady state PK, Combined olaparib and Anastrozole steady state PK. arm 3: Olaparib-alone Steady state PK, Letrozole-alone steady state PK, Combined olaparib and Letrozole steady state PK.

Interventions: intervention 1: Olaparib intervention 2: Tamoxifen intervention 3: Anastrozole intervention 4: Letrozole intervention 5: Pharmacokinetic sampling
Intervention descriptions: intervention 1: 2 x 150mg tablets, twice daily Day 1-5, and Day 27 onwards (Cohort 1), Day 20 onwards (Cohort 2) or Day 39 onwards (Cohort 3) intervention 2: 60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31 intervention 3: 1mg Anastrozole once daily Day 10 - Day 24 intervention 4: 2.5mg Letrozole once daily Day 10 - Day 43 intervention 5: Blood sampling over 12-24 hour period for pharmacokinetic analysis

Protocol document: