Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02042781|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumours||Drug: PG545||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||September 2016|
Once weekly, one hour IV infusion of PG545.
PG545 will be administered once weekly, as a one hour IV infusion. Patients will be treated until they exhibit disease progression, withdraw due to poor tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 250 mg anticipated.
- Determination of maximum tolerated dose (MTD) of PG545 [ Time Frame: Evaluated at the end of initial 28-day cycle ]The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.
- Number of adverse events by cohort [ Time Frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment ]
- Severity of adverse events by cohort [ Time Frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment ]
- Assessment of the anti-tumour activity of PG545 using RECIST criteria [ Time Frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042781
|Nucleus Network Ltd|
|Melbourne, Victoria, Australia, 3004|
|Australia, Western Australia|
|Linear Clinical Research Ltd|
|Nedlands, Western Australia, Australia, 6009|
|Principal Investigator:||Michael Millward, MBBS||Sir Charles Gairdner Hospital|