Close

What are ADC's

Our services

ADC Review
is made possible by:




NCT01976169 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1) (NCT01976169)

Trial Description
Standard of care:
Treatment with Trastuzumab

Experimental:
21-Day Cycle of Combination therapy with ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) intravenously on Day 1 and oral PD-0332991 on Days 5-18

Study Design and Methodology:
This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies.

The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.

A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.

Cohort 1 : PD-0332991 – 100 mg daily (oral) Cohort 2 : PD-0332991 – 150 mg daily (oral) Cohort 3 : PD-0332991 – 200 mg daily (oral)

The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level

Treatment cycles will continue until disease progression or withdrawal from study.

This trial is sponsored by University of Texas Southwestern Medical Center. [1]

Study Data

  • Condition: Advanced Breast Cancer
  • Interventions:
    • Drugs used in this trial
  • Phase: I
  • Estimated Enrollment: 17
  • Start: January 2014
  • Estimated Completion: August 2015
  • Last verified: May 2015

Study Schematic

(Coming soon)

Click here to Return to Drug map


Last Editorial review: July 28, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

Copyright © 2015 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Add to Flipboard Magazine.


Share

Recommended Articles

Four Ways to Show Nonobviousness of ADC Inventions

05 October, 2018

When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000,[1] only a handful of patent applications claiming ADCs had been published.[2] As research cont...


Skip to toolbar