Trial registered on ANZCTR


Trial ID
ACTRN12614000171617
Ethics application status
Approved
Date submitted
3/02/2014
Date registered
11/02/2014
Date last updated
22/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase 1 study of dendrimer-docetaxel (DEP(TM) Docetaxel) in patients with advanced cancer.
Scientific title
A phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours.
Secondary ID [1] 284022 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 291063 0
Condition category
Condition code
Cancer 291406 291406 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DEP(TM) Docetaxel (DTX-SPL8783) / Escalating doses by intravenous infusion, single dose once every cycle (cycle length of 3 weeks). Number of doses (i.e., cycles) and dosage amounts will depend on any toxicities occurring at each dose level. Starting dose of 10mg/m2, increased by 1.4 to 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.
Intervention code [1] 288709 0
Treatment: Drugs
Comparator / control treatment
None - Dose escalation
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291396 0
Determination of the maximum tolerated dose (MTD) as assessed by occurrence of dose limiting toxicities (DLT)
Timepoint [1] 291396 0
During the first cycle of treatment (i.e. the first 3 weeks of treatment)
Secondary outcome [1] 306663 0
General safety and tolerability profile, as determined by adverse events (AE) including ascites, pericardial effusions or pleural effusions. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilised for AE assessment and reporting.
Timepoint [1] 306663 0
Assessed at the end of each cycle of treatment (i.e., every 3 weeks)
Secondary outcome [2] 306664 0
Tumour response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Timepoint [2] 306664 0
Screening, and the end of Cycles 3, 6, 9 etc., while on study
Secondary outcome [3] 306665 0
Pharmacokinetic profile tested via blood assay.
Timepoint [3] 306665 0
Cycle 1 Days 1, 8 and 15, Cycle 2 Day 1

Eligibility
Key inclusion criteria
Patients with histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists; life expectancy of greater than 12 weeks; measurable or evaluable disease by RECIST.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to docetaxel or other components of study therapy or compounds of similar chemical composition; uncontrolled intercurrent illness; participation in a study of an investigational agent within 30 days prior to first study therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 2177 0
The Alfred - Prahran
Recruitment hospital [2] 2850 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 2851 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 3723 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 7857 0
3004 - Melbourne
Recruitment postcode(s) [2] 8539 0
4006 - Herston
Recruitment postcode(s) [3] 8540 0
3084 - Heidelberg
Recruitment postcode(s) [4] 9544 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 288649 0
Commercial sector/Industry
Name [1] 288649 0
Starpharma Pty Ltd
Address [1] 288649 0
4-6 Southampton Crescent, Abbotsford, Victoria 3067
Country [1] 288649 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Starpharma Pty Ltd
Address
4-6 Southampton Crescent, Abbotsford, Victoria 3067
Country
Australia
Secondary sponsor category [1] 287360 0
None
Name [1] 287360 0
Address [1] 287360 0
Country [1] 287360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290500 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 290500 0
Ethics committee country [1] 290500 0
Australia
Date submitted for ethics approval [1] 290500 0
Approval date [1] 290500 0
22/01/2014
Ethics approval number [1] 290500 0
556/13
Ethics committee name [2] 291503 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 291503 0
Office for Research
Level 8, Harold Strokes Building
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Ethics committee country [2] 291503 0
Australia
Date submitted for ethics approval [2] 291503 0
Approval date [2] 291503 0
22/05/2014
Ethics approval number [2] 291503 0
HREC-14/Austin/108

Summary
Brief summary
The study is evaluating the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours.

Who is it for?

You may be eligible to join this study if you are aged over 18 years, have a histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists, a life expectancy greater than 12 weeks, and your disease is measurable or evaluable by the Response Evaluation Criteria In Solid Tumours (RECIST).

Trial details:

Participants in this study will be administered DEP(TM) Docetaxel (DTX-SPL8783) via intravenous infusion in escalating doses once every 3 weeks. The number of doses and dosage amounts administered to participants are dependent on any toxicities occurring at each dose level. The starting dose is 10mg/m2, increased by 1.4 – 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45974 0
Dr Jason Lickliter
Address 45974 0
Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Rd, Melbourne, Victoria 3004
Country 45974 0
Australia
Phone 45974 0
+61 3 90768900
Fax 45974 0
Email 45974 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 45975 0
Dr Jeremy Paull
Address 45975 0
Starpharma Pty Ltd
4-6 Southampton Crescent, Abbotsford, Victoria 3067
Country 45975 0
Australia
Phone 45975 0
+61 3 85322736
Fax 45975 0
Email 45975 0
jeremy.paull@starpharma.com
Contact person for scientific queries
Name 45976 0
Dr Jeremy Paull
Address 45976 0
Starpharma Pty Ltd
4-6 Southampton Crescent, Abbotsford, Victoria 3067
Country 45976 0
Australia
Phone 45976 0
+61 3 85322736
Fax 45976 0
Email 45976 0
jeremy.paull@starpharma.com