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PD0332991/Paclitaxel in Advanced Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PD0332991/Paclitaxel in Advanced Breast Cancer

A Phase 1 Trial of PD0332991 and Paclitaxel in Patients With Rb-Expressing Advanced Breast Cancer

NCT01320592•Abramson Cancer Center at Penn Medicine

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 Eastern Cooperative Oncology Group 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:
•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
•For subjects without extensive bone metastases: alkaline phosphatase levels \< 2.5 x upper normal limit .
•For subjects with extensive bone metastases: alkaline phosphatase levels \< 5 x upper normal limit .
+10 more criteria

Exclusion Criteria

•Patient who has had chemotherapy, radiotherapy or hormonal therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C or bevacizumab), or who has not recovered from the adverse events due to previous agents administered more than 4 weeks prior to Study Day 1. If the patient has residual toxicity from prior treatment, toxicity must be \< Grade 1.
•patients less than 4 weeks post major surgical procedure (all surgical wounds must be fully healed). For the purpose of this criterion, a major surgical procedure is defined as one requiring the administration of general anesthesia.
•Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. However, patients with CNS metastases (including brain metastases) who have completed a course of radiotherapy are eligible for the study provided they are clinically stable. Oral corticosteroids for control of CNS symptoms are allowed.
•Patient has known hypersensitivity to the components of study drug or its analogs.
•The subject has uncontrolled intercurrent illness including, but not limited to Ongoing or active infection
•Diabetes mellitus
•Hypertension
•Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
•Patient has baseline neuropathy of \> grade 2
•Patients who have known allergic reactions to Paclitaxel or IV Contrast Dye despite standard prophylaxis.
+3 more criteria

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 1, 2011

Primary Completion Date

May 1, 2019

Completion Date

May 1, 2019

Last Updated

April 8, 2020

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

PD0332991

DRUG

Paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PD0332991/Paclitaxel in Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer