PD0332991(Palbociclib)/Paclitaxel in Advanced Breast Cancer
PD0332991/Paclitaxel in Advanced Breast Cancer
http://clinicaltrials.gov/ct2/show/N...332991&rank=20 This study is currently recruiting participants. Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania Sponsor: Abramson Cancer Center of the University of Pennsylvania Information provided by (Responsible Party): Abramson Cancer Center of the University of Pennsylvania ClinicalTrials.gov Identifier: NCT01320592 First received: March 16, 2011 Last updated: February 25, 2013 Last verified: February 2013 History of Changes
http://clinicaltrials.gov/ct2/html/i...e/triangle.gif Purpose This study is a phase I, single arm, open-label trial of PD0332991 in combination with Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are anticipated to be enrolled to reach the MTD of PD0332991 in combination with Paclitaxel. Once the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that dose to establish the RP2D, obtain additional safety data and perform exploratory biomarker studies. Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Primary Purpose: Treatment Official Title: A Phase 1 Trial of PD0332991 and Paclitaxel in Patients With Rb-Expressing Advanced Breast Cancer Resource links provided by NLM: Genetics Home Reference related topics: breast cancer retinoblastoma MedlinePlus related topics: Breast Cancer Cancer Drug Information available for: Paclitaxel U.S. FDA Resources Further study details as provided by Abramson Cancer Center of the University of Pennsylvania: Primary Outcome Measures:
Secondary Outcome Measures:
Estimated Enrollment: 20 Study Start Date: March 2011 Estimated Study Completion Date: March 2013 Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure) Detailed Description: This study is a phase I, single arm, open-label trial of PD0332991 in combination with paclitaxel in patients with Rb-expressing metastatic breast cancer. Patients will be treated as shown in the schema below. Up to 20 patients are anticipated to be enrolled to reach the MTD of PD0332991 in combination with Paclitaxel. Once the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that dose to estalish the RP2D, obtain additional safety data and perform exploratory biomarker studies. The primary endpoint will be assessed after one cycle of therapy. Patients will remain on study until dose limiting toxicity, disease progression or physician/patient discretion. Safety assessment will continue for the durationof patient participation. http://clinicaltrials.gov/ct2/html/i...e/triangle.gif Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria:
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