CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 74 enrolled
Drug / intervention
PD-0332991drug
Likely dose
PD-0332991 25–150 mg orally once daily (3/1 schedule: days 1–21 of 28 days) or 100–225 mg orally once daily (2/1 schedule: days 1–14 of 21 days)AI-extracted
Key inclusion· 4
  • Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular/diffuse large cell non-Hodgkin's lymphoma, refractory to or intolerant of established therapy
  • Tumors must express Rb (retinoblastoma protein)
  • ECOG performance status 0, 1, or 2
  • Adequate blood cell counts, kidney function, and liver function
Key exclusion· 3
  • Prior stem cell or bone marrow transplant
  • Uncontrolled infection, unstable or severe intercurrent medical condition, or current drug or alcohol abuse
  • Active or unstable cardiac disease or history of myocardial infarction within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00141297
NCT00141297Phase 1Completed

A Phase I Clinical, Pharmacokinetic, And Pharmacodynamic Evaluation Of 2 Schedules Of Oral PD 0332991, A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer

Pfizer·interventional·Posted Sep 1, 2005·Updated Jan 5, 2016

In Brief

A Phase 1 clinical trial evaluating PD-0332991 for Neoplasms and Lymphoma, Non-Hodgkin. Completed, enrolled 74 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartSep 1, 2004
Primary CompletionJul 1, 2008
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago

Interventions

PD-0332991drug

Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2) 2/1 Schedule - PD-0332991 administered days 1-14 of a 21-days schedule, doses ranging from 100 to 225 mg once daily