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Exelixis, Inc. Message Board

  • erniewerner erniewerner Jan 2, 2013 2:38 PM Flag

    Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

    This is trial number 27 on the clinicaltrials site. It is noteworthy because it has an active control arm. The control arm will receive standard of care paclitaxel (Taxol). Like the MTC trial, this will be a very refractory (advanced) group who have recurrent disease, likely following surgery and adjuvant treatment. The ladies on the control arm will be given Taxol, but it should be noted that they likely received and failed Taxol/platinum therapy one or more times. The trial size is 102 patients. The primary endpoint is PFS. It should be emphasized that this is not being presented as a potentially pivotal trial, however, it is large enough for a clear trend to emerge assuming Comet is as effective as we hope.

    This trial is yet to start recruitment and it is unclear how quickly it will reach full enrollment. It is an NCI trial, they have laid on a number of entry requirements and it may only be available in a limited number of sites. The NCCN recognized Avastin as an approved off-label treatment for frontline and 2nd line Ovarian treatment on the basis of 2 phase 3 trials which have yet to be filed on as the basis for a supplemental NDA.

    EXEL reported RDT Ovarian results at the annual ASCO meeting in 2011. I have been unable to find any update on those results.

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      Jason Konner, MD from the 12/22/12 OncLive piece on emerging agents in OC.

      "Cabozantinib, an oral tyrosine kinase inhibitor (TKI) that recently became FDA-approved to treat medullary thyroid cancer, is being investigated in a number of additional tumor types, including ovarian cancer. “That’s probably the most promising oral TKI for ovarian cancer, having shown the most pronounced response rates in early trials,” Konner said."

      The article goes on to discuss some pros & cons of bevacizumab treatment in OC, and discounts aflibercept for lacking in clinical differentiation from beva. All I've read to date agrees w/ you, Ernie. Cabo stands to enable a solid foothold in OC.


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