Please Read – Protocol update for a Phase II study in cholangiocarcinoma patient

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    gavin
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    Protocol update for a Phase II study in cholangiocarcinoma patients with FGFR genetic alterations: Overview & Frequently Asked Questions.

    Announcing a protocol update: expanding inclusion criteria for QED’s Phase II study evaluating infigratinib (BGJ398) in cholangiocarcinoma patients with FGFR genetic alterations

    QED Therapeutics is opening enrollment in two additional cohorts in the ongoing Phase II study evaluating infigratinib (formerly BGJ398) in cholangiocarcinoma. This update will allow patients with certain FGFR genetic alterations other than FGFR2 fusions as well as patients who have previously received treatment with an FGFR inhibitor to participate, alongside patients who have tumors that harbor FGFR2 fusions and/or translocations as has been permitted to date.

    The update will allow more patients to participate in a clinical study and help to better characterize the drug’s clinical profile in patients with cholangiocarcinoma. QED hopes that by obtaining more data in a larger group of FGFR-altered cholangiocarcinoma patients, a broader group of patients may benefit from infigratinib treatment.

    Why is the protocol changing?

    The protocol is changing to allow a wider group of patients to be studied in this clinical trial. Doing so will provide more information to characterize infigratinib’s clinical profile in distinct patient groups and may ultimately allow a broader population of cholangiocarcinoma patients to benefit from this investigational medicine.

    Who can enroll in this clinical trial?

    Patients with advanced or metastatic cholangiocarcinoma whose tumors harbor FGFR2 fusions can continue to enroll in this trial as before. In addition, the expansion includes two additional cohorts:

    (1) the first additional cohort will allow patients with certain FGFR activating mutations or FGFR1 or FGFR3 fusions and/or translocations to enroll and

    (2) the second additional cohort will allow patients with FGFR2 fusions or translocations who have previously received treatment with an FGFR inhibitor to enroll.

    For full enrollment details please visit http://www.clinicaltrials.gov under the Identifier NCT02150967 and consult your physician.

    https://clinicaltrials.gov/ct2/show/NCT02150967

    Where are there participating clinical trial sites that are enrolling the new cohorts?

    All already-participating trial sites for this study are adapting their protocols to enable enrollment of patients for these additional cohorts. The time to implement these changes varies by site, so the exact timing of open enrollment for the new cohorts will be different at every location. A complete list of participating trial sites can be found at http://www.clinicaltrials.gov under the Identifier NCT02150967 and consult your physician to discuss the trial more.

    Where can I find more information?

    If you are interested in learning more, talk to your physician. Additional information can also be found by visiting http://www.clinicaltrials.gov under the Identifier NCT02150967 and consult your physician to discuss the trial more.

    Infigratinib is an investigational agent. The safety and efficacy of infigratinib in cholangiocarcinoma have not been established. QED makes no claim that infigratinib will become commercially available in any country for the uses being investigated.

    https://clinicaltrials.gov/ct2/show/NCT02150967

    Gavin

     

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