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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00543712




Registration number
NCT00543712
Ethics application status
Date submitted
12/10/2007
Date registered
15/10/2007
Date last updated
27/06/2013

Titles & IDs
Public title
A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
Scientific title
A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma
Secondary ID [1] 0 0
APM4171g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chondrosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRO95780

Treatment: Drugs: PRO95780
Intravenous repeating dose

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Primary outcome [2] 0 0
Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
Timepoint [2] 0 0
Primary outcome [3] 0 0
Objective response
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Duration of objective response
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Progression-free survival
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Pharmacokinetic parameters
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Ability to understand and willingness to sign a written informed consent document

- Age = 18 years

- Histologic diagnosis of chondrosarcoma, verifiable after enrollment

- Measurable disease

- Previously treated or incurable disease without options for standard of care therapy

- ECOG performance status of 0-2

- Life expectancy of > 3 months

- For patients of reproductive potential (males and females), use of reliable means for
contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier)
throughout the trial and for 1 year following their final exposure to study treatment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Systemic therapy or radiotherapy within 4 weeks prior to Day 1

- Prior therapy with agents targeting the DR5 apoptosis pathway

- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks
prior to Day 1, or anticipation of need for major surgical procedure during the course
of the study

- Other invasive malignancies within 5 years prior to Day 1

- Known active brain metastases

- Uncontrolled intercurrent illness, including but not limited to ongoing or active
infection requiring parenteral antibiotics at enrollment

- Clinically significant, symptomatic cardiovascular disease, New York Heart Association
(NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade
II or greater peripheral vascular disease, or history of major heart surgery within 6
months of Day 1, or any situation that would likely limit compliance with study
requirements

- Known to be positive for hepatitis C or hepatitis B surface antigen

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates use of an investigational drug or that might affect interpretation of
the results of the study or render the patient at high risk for treatment
complications

- Use of anticoagulation therapy

- Participation in clinical trials or undergoing other investigational procedures within
30 days prior to Day 1

- Pregnancy or breast feeding

- Known sensitivity to any of the products administered during the study

- Any disorder that compromises the ability of the patient to give written informed
consent and/or comply with study procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and
safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up
to 90 patients with confirmed chondrosarcoma will be enrolled.
Trial website
https://clinicaltrials.gov/show/NCT00543712
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandra Skettino, M.D.
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00543712