HonCode

Go Back   HER2 Support Group Forums > Clinical Trials
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 10-16-2013, 11:21 AM   #1
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Post 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


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.


Condition Intervention Phase Breast Cancer
Drug: PD0332991
Drug: Paclitaxel
Phase 1

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:
  • To Determine the Adverse Events of PD0332991 [ Designated as safety issue: Yes ]To determine the maximally-tolerated dose and safety of PD0332991 in combination with a fixed, weekly dose of Paclitaxel of 80 mg/m2 and to characterize the safety of the combination during the first three cycles of therapy.


Secondary Outcome Measures:
  • Maximally Tolerated Dose in an expanded Cohort of Breast Cancer Patients [ Designated as safety issue: Yes ]To explore the activity of the combination at the MTD in an expanded cohort of breast cancer patients.
  • To explore the relationship between selected biomarkers and efficacy, tolerability and safety outcomes [ Designated as safety issue: Yes ]To explore the relationship between selected biomarkers and efficacy, tolerability and safety outcomes


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.




Eligibility

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria
Inclusion Criteria:
  • Patient must have histologically or cytologically-confirmed metastatic breast cancer. Any ER, PR or Her2 status is allowed.
  • Tumor must express Retinoblastoma (Rb) protein, as defined as any measureable staining by immunohistochemistry
  • Male or female and > 18 years of age on the day of signing informed consent.
  • Patient must have received < prior cytotoxic regimens for metastatic breast cancer. This does not include cytoxic regimens used in the adjuvant setting.
  • Performance status of 0-1 on the ECOG Performance Scale and life expectancy > 3 months.
  • patient on the dose-escalation portion of the trial must have evaluable disease, defined as either measurable (by RECIST) or non-measurable disease (e.g. bone mets, pleural effusion or lymphangitic spread). Measurable disease is required for patients in the expanded RP2D cohort.
  • The subject must have adequate organ function, defined as follows: (click on link above for more information)

Last edited by 'lizbeth; 10-16-2013 at 11:22 AM.. Reason: addition
'lizbeth is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -7. The time now is 06:10 AM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2017, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007
free webpage hit counter