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Exelixis, Inc. Message Board

  • wilderguide wilderguide Sep 19, 2013 2:19 PM Flag

    NCT00596648 update

    $$$$
    "A Study of XL-184 w/ and w/o erlotinib in adults w/ NSCLC"
    This P1/2 study updated on 9/17/13 with "This study has been completed"
    I would expect fairly robust results, as this trial combination has been repeated in two further P2 studies.
    ESMO 2013 is a likely venue for these results to present, and I don't see a pending disappointment here...
    Particularly if we get a viable OS signal from this 5-yr study.
    GLTA

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    • ""A Study of XL-184 w/ and w/o erlotinib in adults w/ NSCLC"
      This P1/2 study updated on 9/17/13 with "This study has been completed"
      I would expect fairly robust results, as this trial combination has been repeated in two further P2 studies."

      Let's talk about this trial a little bit. It was last reported on in May 2010 in a company press release. Later that year is when BMY pulled out and EXEL went all in on CRPC. They shelved R&D and cancelled plans for a an XL184 glioblastoma pivotal trial. It was in November 2010 that they submitted a status change to the XL+erlotinib trial listing its status as terminated. That usually means that the trial funding was pulled. At any rate, recruitment stopped. That was almost 3 years ago. I don't think we will ever see any more results of that particular trial published. That said, with the NIH funding, the program has been restarted and I am sure EXEL made the prior results available to the new trial sponsors.

      • 1 Reply to erniewerner
      • $$$$
        "As of the cut-off date of March 25, 2010, 54 patients have been treated in five combination dose cohorts, ranging from 50 mg XL184/150 mg erlotinib to 125 mg XL184/50 mg erlotinib. The vast majority of patients (52/54) had received prior erlotinib therapy. The MTD for the erlotinib maximized arm was determined to be 50 mg XL184/150 mg erlotinib; the preliminary MTD for the XL184 maximized arm of the study is 125 mg XL184/50 mg erlotinib and the cohort is being expanded.

        Thirty four of 44 (77%) patients with at least one post-baseline scan demonstrated tumor shrinkage as their best response following a median of 2 prior lines of therapy. Two patients with tumor shrinkage also showed evidence of MET copy number gain (cng). Four of 53 (8%) patients evaluable for response assessment had a confirmed partial response per RECIST criteria.

        "We are very encouraged by the data generated thus far in the phase 1 portion of this study. We believe that these results with the XL184-erlotinib combination and the early single-agent XL184 signal from the NSCLC cohort seen in a separate randomized discontinuation trial, also presented at ASCO, will support phase 2 evaluation of XL184 alone and in combination with erlotinib in patients with non-small cell lung cancer," said Michael M. Morrissey, Ph.D., president of research and development at Exelixis. "The evidence of clinical activity, particularly in refractory NSCLC patients previously treated with erlotinib or with drug-resistant EGFR mutations and/or MET copy number gain is of particular note, given the poor prognoses that these patients typically "

        Ernie, there's a lot of good info in this old PR, particularly wrt dosing MTD's. This PR predates the recognition of the bone scan phenom(Nov 2010) as well as the reporting of the Grade 5 AE's that were reported in 2011. The secondary end points in this NSCLC trial included OS. Do you see that NIH funding would've been forthcoming in the absence of a favorable OS signal?

 
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