PD0332991/Paclitaxel in Advanced Breast Cancer
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ClinicalTrials.gov Identifier: NCT01320592 |
Recruitment Status :
Completed
First Posted : March 22, 2011
Last Update Posted : April 8, 2020
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Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
Tracking Information | |||
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First Submitted Date ICMJE | March 16, 2011 | ||
First Posted Date ICMJE | March 22, 2011 | ||
Last Update Posted Date | April 8, 2020 | ||
Actual Study Start Date ICMJE | March 2011 | ||
Actual Primary Completion Date | May 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
To Determine the Adverse Events of PD0332991 [ Time Frame: weekly paclitaxel at a fixed dose of 80 mg/m2 and to assess the safety of the combination after 3 cycles of therapy (cycles are 28 days) . ] 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.
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Original Primary Outcome Measures ICMJE |
To Determine the Adverse Events of PD0332991 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.
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | PD0332991/Paclitaxel in Advanced Breast Cancer | ||
Official Title ICMJE | A Phase 1 Trial of PD0332991 and Paclitaxel in Patients With Rb-Expressing Advanced Breast Cancer | ||
Brief Summary | 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 Maximum Tolerated Dose (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 Recommended Phase 2 Dose (RP2D), obtain additional safety data and perform exploratory biomarker studies. | ||
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 establish 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 duration of patient participation. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: PD0332991 and Paclitaxel
PD0332991 in combination with weekly paclitaxel at a fixed dose of 80 mg/m2
Interventions:
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Publications * | Clark AS, McAndrew NP, Troxel A, Feldman M, Lal P, Rosen M, Burrell J, Redlinger C, Gallagher M, Bradbury AR, Domchek SM, Fox KR, O'Dwyer PJ, DeMichele AM. Combination Paclitaxel and Palbociclib: Results of a Phase I Trial in Advanced Breast Cancer. Clin Cancer Res. 2019 Apr 1;25(7):2072-2079. doi: 10.1158/1078-0432.CCR-18-0790. Epub 2019 Jan 11. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
28 | ||
Original Estimated Enrollment ICMJE |
20 | ||
Actual Study Completion Date ICMJE | May 2019 | ||
Actual Primary Completion Date | May 2019 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Bilirubin < 1.5 x upper normal limit or calculated creatinine clearance > 60 mL/min, and for subjects without liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper normal limit
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01320592 | ||
Other Study ID Numbers ICMJE | UPCC 02111 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Abramson Cancer Center of the University of Pennsylvania | ||
Original Responsible Party | Angela DeMichele, Abramson Cancer Center of the University of Pennsylvania | ||
Current Study Sponsor ICMJE | Abramson Cancer Center of the University of Pennsylvania | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Abramson Cancer Center of the University of Pennsylvania | ||
Verification Date | April 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |