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NCT00141297 · ClinicalTrials.gov registry record · Phase 1
A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer
A Phase 1 study of Neoplasms and Lymphoma, Non-Hodgkin, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 4
- Study locations
NCT00141297: Completed Phase 1 study of Neoplasms and Lymphoma, Non-Hodgkin, sponsored by Pfizer.
NCT00141297 is a Phase 1 study of Neoplasms and Lymphoma, Non-Hodgkin that has completed, run by Pfizer. The registered enrollment target is 74 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00141297, a Phase 1 study of Neoplasms and Lymphoma, Non-Hodgkin, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 4
- Study locations
Study Summary
PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.
Primary Outcome
DLT: an adverse event occurring after initiation of PD 0332991 that met any following criteria: 1) Grade 4 hematologic toxicity (platelets less than \[\<\] 25000 per microliter (mcL), absolute neutrophil count \[ANC\] \<500/mcL, hemoglobin \[Hb\] \<6.5 gram per deciliter \[g/dL\]; 2) ANC \<1000/mcL associated with documented infection or fever greater than or equal to (\>=) 38.5 degrees Celsius; 3) \>=Grade 3 non-hematologic treatment-related toxicity. In an asymptomatic participant, Grade 3 cor
Conditions Studied
Interventions
- DRUG PD-0332991
Study Locations (4)
Pennsylvania
- Abramson Cancer Center Hospital of the University of Pennsylvania - Philadelphia
- Pharmacy/PCAM/West Pavillion - Philadelphia
Michigan
- Karmanos Cancer Institute - Detroit
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2004-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT00141297 record still lists
NCT00141297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which PD-0332991 is the first listed.
NCT00141297 reports a single indexed study location in Pennsylvania, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT00141297 about?
NCT00141297 is a clinical study titled "A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer". PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.
What is the current status of trial NCT00141297?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2004-09. Estimated completion is 2014-12.
What conditions does trial NCT00141297 study?
This clinical trial studies the following conditions: Neoplasms, Lymphoma, Non-Hodgkin.
What interventions are being tested in trial NCT00141297?
The interventions under investigation include: PD-0332991 (DRUG).
Who is sponsoring clinical trial NCT00141297?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00141297 being conducted?
This trial has 4 study locations across Michigan, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00141297's enrollment target sits among peer trials
74 85th of 158 higher than 73 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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