Safety study of LX1606 in symptomatic carcinoid syndrome

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Multi-Center, Serial Ascending-Dose, Dose Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects with Symptomatic Carcinoid Syndrome

• IRAS ID

  69004

• Contact name

  Martyn Caplin

• Sponsor organisation

  Lexicon Pharmaceuticals, Inc

• Eudract number

  2009-016973-13

• Clinicaltrials.gov Identifier

  NCT01104415

• Research summary

  The study will be conducted as a Phase 2, multi-center, open-label, serial-ascending dose, individual titration, multi-dose study in subjects with symptomatic carcinoid syndrome.There are currently no specific oral treatments indicated for the management of symptoms associated with carcinoid syndrome. As a result of the side-effects associated with somatostatin analogs, (the current standard of care) and the associated tachyphylaxis, there is an unmet medical need formsymptom management in patients with metastatic carcinoid tumor. Inhibition of the excessive 5-HT (serotonin) produced by these tumors with an orally delivered agent such as LX1606 could provide significant benefit as an alternative treatment option for patients and clinicians.LX1606 is being developed to manage gastrointestinal (GI) symptoms and possibly otherisymptoms associated with carcinoid syndrome (caused by metastatic carcinoid tumor).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/H0717/4

• Date of REC Opinion

  16 Mar 2011

• REC opinion

  Further Information Favourable Opinion