ChondrosarcomaPhase 2NCT00543712
A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
A Phase 2 study testing PRO95780 in people with Chondrosarcoma, run by Genentech, Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chondrosarcoma
- What is being tested?
- PRO95780
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 31 May 2007to 5 May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center
Houston, Texas, 77030
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma
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.
- Conditions
- Chondrosarcoma
- Being tested
- PRO95780
- Keywords
- Sarcoma, synovial sarcoma, APM4171g
- Medical subject headings
- Chondrosarcoma, Sarcoma, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO95780Drug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| PRO95780 | Experimental | Not described Receives: Drug: PRO95780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
Objective response
Secondary outcomes (4)
Duration of objective response
Progression-free survival
Overall survival
Pharmacokinetic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study start31 May 2007
- Primary completion5 May 2008
- Study completion5 May 2008
Why it stopped: Efficacy not evident in this population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChondrosarcomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Skettino, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543712
- Sponsor's protocol ID
- APM4171g
- Status last verified
- Dec 2022
- First submitted
- 12 Oct 2007
- Last updated
- 13 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma
- ClinicalTrials.gov ID
- NCT00543712
- Acronym / sponsor ID
- APM4171g
- Conditions
- Chondrosarcoma
- Keywords
- Sarcoma, synovial sarcoma, APM4171g
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy not evident in this population.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2007 (actual)
- Primary completion
- 5 May 2008 (actual)
- Study completion
- 5 May 2008 (actual)
- First posted
- 15 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRO95780 | Experimental | Drug: PRO95780 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO95780Intravenous repeating dose | Drug | PRO95780 |
Primary outcome
Adverse events
Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
Objective response
4 secondary outcomes
Duration of objective response
Progression-free survival
Overall survival
Pharmacokinetic parameters
Results and safety
The study was stopped early (reason given: Efficacy not evident in this population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Skettino, M.D. study director
Genentech, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRO95780 in people with Chondrosarcoma, run by Genentech, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Efficacy not evident in this population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.