NeoplasmsPhase 3NCT00037791
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 Neoplasms and Thrombocytopenia, run by Pfizer at 9 sites in 3 countries.
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 18 years and older
- Conditions the study is for
- Neoplasms, Thrombocytopenia, Multiple Myeloma
- What is being tested?
- (PN-152,243)/PN-196,444
- How many people
- 180 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Dec 1999to Sep 2002
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support
Who cannot join
- Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States6 sites
Pfizer Investigational Site
Berkeley, California, 94704
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Los Angeles, California, 90033-0804
Pfizer Investigational Site
Los Angeles, California, 90067
Pfizer Investigational Site
New Orleans, Louisiana, 70115
Argentina2 sites
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1114
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1406
About this study
Official title: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Patients Receiving Myelosuppressive Treatment Regimens Requiring Platelet Transfusion Support.
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 this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.
- Conditions
- Neoplasms, Thrombocytopenia, Multiple Myeloma, Lymphoma, Malignant
- Being tested
- (PN-152,243)/PN-196,444
- Medical subject headings
- Neoplasms, Thrombocytopenia, Multiple Myeloma, Lymphoma
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 two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.
Secondary outcomes (8)
Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and 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 will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
Assess the safety of multiple intravenous doses of rhTPO
Determine the occurrence and clinical implications of any anti-rhTPO antibodies
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Evaluate the impact of rhTPO administration on patient quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2002 (estimated)
- Study startDec 1999
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 180 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
- NCT00037791
- Sponsor's protocol ID
- 98-OTPO-005
- Status last verified
- Sep 2006
- First submitted
- 21 May 2002
- Last updated
- 9 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2006. 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 in Patients Receiving Myelosuppressive Treatment Regimens Requiring Platelet Transfusion Support.
- ClinicalTrials.gov ID
- NCT00037791
- Acronym / sponsor ID
- 98-OTPO-005
- Conditions
- Neoplasms, Thrombocytopenia, Multiple Myeloma, Lymphoma, Malignant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 1999
- Study completion
- Sep 2002
- First posted
- 22 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 this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support
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 two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.
8 secondary outcomes
Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and 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 will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
Assess the safety of multiple intravenous doses of rhTPO
Determine the occurrence and clinical implications of any anti-rhTPO antibodies
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Evaluate the impact of rhTPO administration on patient quality of life
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 9 Nov 2006.
- 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
9 sites in 3 countries: 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 Neoplasms and Thrombocytopenia, run by Pfizer at 9 sites in 3 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 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 9 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Argentina, Mexico. 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 two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for 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 9 Nov 2006.