SarcomaPhase 3NCT00038311
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
A Phase 3 study testing PN-152,243)/PN-196,444 in people with Sarcoma, run by Pfizer at 6 sites in United States.
Trial summary
Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- PN-152,243)/PN-196,444
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2000to Mar 2003
- Phase
- Phase 3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy
Who cannot join
- Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Los Angeles, California, 90067
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19106
Pfizer Investigational Site
Radnor, Pennsylvania, 19087
About this study
Official title: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))
Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.
- Conditions
- Sarcoma
- Being tested
- PN-152,243)/PN-196,444
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN-152,243)/PN-196,444Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
Secondary outcomes (10)
Identify the effect of rhTPO on the number of platelet transfusions.
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis.
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia.
Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
Assess the safety of multiple IV doses of rhTPO.
Determine the occurrence and clinical implications of any anti-TPO antibodies.
Assess the antitumor activity of AI chemotherapy.
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
Evaluate the impact of rhTPO prophylaxis on patient quality of life.
Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2002 (estimated)
- Study startSep 2000
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038311
- Sponsor's protocol ID
- 444-ONC-0003-020
- Status last verified
- Apr 2015
- First submitted
- 30 May 2002
- Last updated
- 4 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))
- ClinicalTrials.gov ID
- NCT00038311
- Acronym / sponsor ID
- 444-ONC-0003-020
- Conditions
- Sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Study completion
- Mar 2003 (actual)
- First posted
- 31 May 2002 (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.
Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy
Key exclusion criteria (1 listed)
- Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
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 |
|---|---|---|
| PN-152,243)/PN-196,444 | Drug | – |
Primary outcome
To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
10 secondary outcomes
Identify the effect of rhTPO on the number of platelet transfusions.
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis.
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia.
Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
Assess the safety of multiple IV doses of rhTPO.
Determine the occurrence and clinical implications of any anti-TPO antibodies.
Assess the antitumor activity of AI chemotherapy.
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
Evaluate the impact of rhTPO prophylaxis on patient quality of life.
Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PN-152,243)/PN-196,444 in people with Sarcoma, run by Pfizer at 6 sites in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.. 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 4 May 2015.