Advanced Solid Tumours
Conditions
Keywords
PG545, Phase I, Progen, antimetastatic, antiangiogenic, advanced cancer patients, solid tumors, solid tumours
Brief summary
This first-in-human study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.
Interventions
DRUGPG545
PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.
Sponsors
Statistical Revelations Pty Ltd
Datapharm Australia Pty Ltd
Zucero Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years. * Histological or cytological documentation of non hematologic, malignant solid tumour. * Have failed at least one previous therapeutic regimen. * Measurable disease according to RECIST 1.1. * Life expectancy \>= 12 weeks * ECOG Performance Status of 0 or 1 * Written, signed and dated informed consent * Able and willing to meet all protocol-required treatments, investigations and visits. * Have adequate organ function
Exclusion criteria
* Clinically significant non-malignant disease. * Active CNS metastases. * Subjects with uncontrolled diabetes. * History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents * History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies. * Concomitant use of aspirin (\> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other anti-platelet drugs. * History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media * Known seropositivity to the human immunodeficiency virus (HIV) * Women who are pregnant or breast-feeding. * Women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception. * Active substance abuse * Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) Based on DLT | Following first 1 month cycle | The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort. |
Countries
Australia
Participant flow
Recruitment details
Patients were recruited from Perth oncology clinics and treated under the PG545101 protocol at the dedicated phase I unit, Linear Clinical Research Ltd. The recruitment period was November 2010 to October 2011.
Participants by arm
| Arm | Count |
|---|---|
| 25 mg Dose 25 mg PG545/week | 3 |
| 50 mg Dose 50 mg PG545/week | 1 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease progression | 1 | 0 |
Baseline characteristics
| Characteristic | 50 mg Dose | 25 mg Dose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 57 years | 63 years STANDARD_DEVIATION 5 | 62 years STANDARD_DEVIATION 5 |
| Region of Enrollment Australia | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 1 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) Based on DLT
The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.
Time frame: Following first 1 month cycle
Population: Patients had to complete cycle 1 per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 25 mg Dose | Maximum Tolerated Dose (MTD) Based on DLT | 0 DLTs |
| 50 mg Dose | Maximum Tolerated Dose (MTD) Based on DLT | 1 DLTs |