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 09-19-2013, 12:25 PM   #1
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Post Phase I Dose-escalation Trial of ARRY-380 in Combination With Trastuzumab in Particip

More options for Her2 brain mets:

ClinicalTrials.gov Identifier:
NCT01921335

Purpose The purpose of this study is to test the safety of different doses of ARRY-380 in combination with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2 metastatic breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet been tested. Both agents block the HER2 receptor, which is thought to be overactive in HER2-positive breast cancer. It is thought that ARRY-380 and trastuzumab might work together because they attach to different parts of the HER2 receptor and prevent it from functioning. Because HER2 positive breast cancer contains high levels of HER2 receptor, but normal cells in your body generally do not, the drugs may be able to "target" the cancer cells. In addition, in laboratory studies, ARRY-380 appears to have some penetration into the brain.


http://www.clinicaltrials.gov/ct2/sh...astasis&rank=9




'lizbeth is offline   Reply With Quote
Old 06-23-2014, 07:34 AM   #2
KirisMum
Senior Member
 
Join Date: Nov 2010
Posts: 186
Re: Phase I Dose-escalation Trial of ARRY-380 in Combination With Trastuzumab in Part

Yes, this is the trial Kiri's on, Liz. She is in the lower dose arm, 750mg once a day I believe.
KirisMum is offline   Reply With Quote
Old 06-23-2014, 09:57 AM   #3
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Re: Phase I Dose-escalation Trial of ARRY-380 in Combination With Trastuzumab in Part

I checked the primary completion date: November 2016
There may be interim reports.

I want to thank Kiri for enrolling in the trial. She is the pioneer that will help to determine effective doses and side effects.

This trial sounds very promising for CNS mets. She is in our hearts and prayers for an outstanding result.

Primary Outcome Measures:
  • Determine Maximum-tolerated dose of ARRY-380 with Trastuzumab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To determine the maximum-tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ARRY-380 in combination with trastuzumab in participants with HER2+ breast cancer and central nervous system (CNS metastasis)



Secondary Outcome Measures:
  • CNS objective response rate according to volumetric criteria [ Time Frame: 2 Years ] [ Designated as safety issue: No ]CNS objective response rate according to volumetric criteria

  • Non-CNS objective response rate according to RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]Non-CNS objective response rate according to RECIST 1.1

  • Proportion of participants with stable or responsive disease in both CNS and non-CNS at 16 and 24 weeks. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Proportion of participants with stable or responsive disease in both CNS and non-CNS at 16 and 24 weeks.

  • Progression-free survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Progression-free survival

  • Clinical benefit (CR, PR, or SD>/=24 weeks) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Clinical benefit (CR, PR, or SD>/=24 weeks)

  • Overall survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Overall survival

  • CNS Response according to modified RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]


Estimated Enrollment: 50 Study Start Date: August 2013 Estimated Study Completion Date: November 2019 Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
'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 11:52 PM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2024, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021
free webpage hit counter