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.
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)