Trial Outcomes & Findings for Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours (NCT NCT01252095)
NCT ID: NCT01252095
Last Updated: 2017-10-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Following first 1 month cycle
Results posted on
2017-10-09
Participant Flow
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.
Participant milestones
| Measure |
25 mg Dose
25 mg PG545/week
|
50 mg Dose
50 mg PG545/week
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
25 mg Dose
25 mg PG545/week
|
50 mg Dose
50 mg PG545/week
|
|---|---|---|
|
Overall Study
Disease progression
|
1
|
0
|
Baseline Characteristics
Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Baseline characteristics by cohort
| Measure |
25 mg Dose
n=3 Participants
25 mg PG545/week
|
50 mg Dose
n=1 Participants
50 mg PG545/week
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 5 • n=5 Participants
|
57 years
n=7 Participants
|
62 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following first 1 month cyclePopulation: Patients had to complete cycle 1 per protocol.
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.
Outcome measures
| Measure |
25 mg Dose
n=2 Participants
25 mg PG545/week
|
50 mg Dose
n=1 Participants
50 mg PG545/week
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) Based on DLT
|
0 DLTs
|
1 DLTs
|
Adverse Events
25 mg Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
25 mg Dose
n=3 participants at risk
25 mg PG545/week
|
50 mg Dose
n=1 participants at risk
50 mg PG545/week
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness at injection site
|
33.3%
1/3 • Number of events 4 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
0.00%
0/1 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
100.0%
3/3 • Number of events 14 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
0.00%
0/1 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
|
Skin and subcutaneous tissue disorders
Cellulitus around umbilicus
|
33.3%
1/3 • Number of events 1 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
0.00%
0/1 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
|
Vascular disorders
Facial flushing
|
33.3%
1/3 • Number of events 1 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
0.00%
0/1 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
|
General disorders
Fever
|
0.00%
0/3 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
100.0%
1/1 • Number of events 2 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
|
Skin and subcutaneous tissue disorders
Local reactions
|
0.00%
0/3 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
100.0%
1/1 • Number of events 2 • Patients were on treatment for up to 51 days. Adverse events were collected from signing of informed consent.
|
Additional Information
Director of Clinical Development
Progen Pharmaceuticals Ltd
Phone: +61 7 32739133
Results disclosure agreements
- Principal investigator is a sponsor employee No data may be published or presented from the study except with the prior written consent of Progen. Progen reserves the right to a 30-day review and approval of all manuscripts related to the study prior to publication.
- Publication restrictions are in place
Restriction type: OTHER