Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

This study has been terminated.

(Unexpected injection site reactions.)

Sponsor:

Collaborators:

Statistical Revelations Pty Ltd

Datapharm Australia Pty Ltd

Information provided by (Responsible Party):

Progen Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01252095

First received: November 30, 2010

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

Results First Received: May 21, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Advanced Solid Tumours
Intervention:	Drug: PG545

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
25 mg Dose	25 mg PG545/week
50 mg Dose	50 mg PG545/week

Participant Flow: Overall Study

	25 mg Dose	50 mg Dose
STARTED	3	1
COMPLETED	2	1
NOT COMPLETED	1	0
Disease progression	1	0

Baseline Characteristics

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Reporting Groups

	Description
25 mg Dose	25 mg PG545/week
50 mg Dose	50 mg PG545/week
Total	Total of all reporting groups

Baseline Measures

	25 mg Dose	50 mg Dose	Total
Number of Participants [units: participants]	3	1	4
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	2	1	3
>=65 years	1	0	1
Age [units: years] Mean ± Standard Deviation	63 ± 5	57	62 ± 5
Gender [units: participants]
Female	2	1	3
Male	1	0	1
Region of Enrollment [units: participants]
Australia	3	1	4

Outcome Measures

1. Primary:

Maximum Tolerated Dose (MTD) Based on DLT [ Time Frame: Following first 1 month cycle ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to unexpected injection site reactions leading to small numbers of subjects analyzed. An MTD could not be determined for this study.

Results Point of Contact:

Name/Title: Director of Clinical Development
Organization: Progen Pharmaceuticals Ltd
phone: +61 7 32739133

No publications provided

Responsible Party:	Progen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01252095 History of Changes
Other Study ID Numbers:	PG545101
Study First Received:	November 30, 2010
Results First Received:	May 21, 2012
Last Updated:	June 26, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

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