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-   -   Phase I Dose-escalation Trial of ARRY-380 in Combination With Trastuzumab in Particip (http://her2support.org/vbulletin/showthread.php?t=59050)

'lizbeth 09-19-2013 12:25 PM

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





KirisMum 06-23-2014 07:34 AM

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.

'lizbeth 06-23-2014 09:57 AM

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)


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