Solid Tumours Clinical Trial
Official title:
A Non-randomised, Open-label, Sequential, Three-part, Phase I Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib Following Oral Dosing of a Tablet Formulation, and to Provide Data on the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours
This is a 3-part study in patients with advanced solid tumours: Part A will assess the effect of itraconazole on the PK parameters of olaparib and will determine the effect of olaparib on the QT interval following single oral dosing; Part B will determine the effect of olaparib on the QT Interval following multiple oral dosing; Part C will allow patients continued access to olaparib after the PK and QT phases and will provide for additional safety data collection. A total of 48 patients are planned to be enrolled; at least 42 evaluable patients will be required to complete the study. Patients will participate as a single cohort in all parts of the study.
n/a
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03315091 -
Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours
|
Phase 1 | |
| Completed |
NCT01921140 -
To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
|
Phase 1 | |
| Completed |
NCT00732420 -
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT03572192 -
Tissue Collection Framework To Improve Outcomes In Solid Tumours
|
||
| Completed |
NCT02360345 -
Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly
|
Phase 1 | |
| Completed |
NCT02264418 -
Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours
|
Phase 1 | |
| Completed |
NCT02093351 -
To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
|
Phase 1 | |
| Completed |
NCT01956669 -
Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT02263950 -
A Phase 1/2a Study of LON002 in Subjects With Advanced Solid Tumours
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02215850 -
Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
|
Phase 1 | |
| Completed |
NCT01931761 -
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
|
Phase 1 | |
| Completed |
NCT00136578 -
Ispinesib In Combination With Carboplatin In Patients With Solid Tumors
|
Phase 1 | |
| Completed |
NCT01184274 -
A Phase I Study of SB939 in Pediatric Patients With Refractory Solid Tumours and Leukemia
|
Phase 1 | |
| Withdrawn |
NCT03266159 -
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT01894256 -
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function
|
Phase 1 | |
| Completed |
NCT01974349 -
To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT02923947 -
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
|
Phase 1 | |
| Completed |
NCT02063204 -
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02056392 -
To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT00742131 -
A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors
|
Phase 1 |