Solid Tumours Clinical Trial
Official title:
A Phase I Trial of GSK1120212 and GSK1120212 in Combination With Gemcitabine in Japanese Subjects With Solid Tumors
This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This study is designed to identify recommended doses and regimens in Japanese subjects for the future development of GSK1120212.
GSK1120212 has demonstrated anti-proliferative activity against a broad range of tumors cell
lines and xenograft models. To date, MEK inhibitors have demonstrated evidence of both
pharmacodynamic and clinical activity in early trials.
This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This
study is designed to identify recommended doses and regimens in Japanese subjects for the
future development of GSK1120212.
This study will be conducted in subject with solid tumors, and GSK1120212 single agent
treatment to assess safety, tolerability, PK and efficacy (Part 1) and combination treatment
with gemcitabine in subjects with non-small cell lung cancer, pancreatic cancer, biliary
cancer, urothelial cancer or other tumor types for which gemcitabine has been approved in
4-week schedule to assess safety, tolerability, PK and efficacy(Part 2) will be conducted in
the same protocol.
;
| 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 |
NCT01900028 -
To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients 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 |