Malignant Solid Tumour Clinical Trial
Official title:
A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors
This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10, 20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the safety profile and antitumor effect of OPB-51602 at the recommended dose.
In expansion stage part 1, up to 20 advanced sold tumor subjects will be investigated the safety profiled and antitumor effect of OPB-51602 at the recommended dose for 3 weeks per cycle（2 weeks treatment and 1 week washout). In the expansion stage part 2, a maximum of 20 subjects with Non-small cell lung cancer (NSCLC), Melanoma or Gastrointestinal Stromal Tumor (GIST) will be treated until an investigational Medicinal product (IMP) efficacious case can be found. subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in cycle 1. After safety and tolerability are confirmed, same subjects will be treated at the MTD(5mg) from cycle 2 onwards as a once-daily oral dose for 4 weeks per cycle to obtain additional information about safety, tolerability and antitumor activity of OPB-51602 ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01721148 -
A Phase I Multiple Ascending Dose Study of ASLAN002 in Subjects With Advanced or Metastatic Solid Tumours
|
Phase 1 | |
| Completed |
NCT00551096 -
Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01023737 -
Hydroxychloroquine + Vorinostat in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01435096 -
BN80927 in Patients With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Completed |
NCT01951846 -
To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours
|
Phase 1 | |
| Completed |
NCT01325558 -
A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01554371 -
Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01286896 -
Use of Individual Pharmacokinetically (PK)-Guided Sunitinib Dosing: A Feasibility Study in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT01309490 -
Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT00635791 -
Phase I Study of Vorinostat and Sorafenib in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT01376505 -
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00388427 -
Safety Study Of Cetuximab Plus Dasatinib (BMS-354825) in Treating Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01611857 -
Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach
|
Phase 1/Phase 2 | |
| Completed |
NCT02853903 -
Comparison of Autogenic and Allogenic NK Immunotherapy on the Outcome of Recurrent Solid Tumors
|
Phase 2 | |
| Completed |
NCT02843204 -
Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01618136 -
An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects With Advanced Solid Tumors or With B-cell Malignancies and in Combination With Temozolomide (TMZ) or With Carboplatin and Paclitaxel in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT00801151 -
Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02786628 -
Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation
|
||
| Completed |
NCT00969410 -
A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases
|
Phase 1 | |
| Completed |
NCT02857920 -
Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors
|
Phase 1/Phase 2 |