LDK378-Dose Escalation/Expansion study in patients with ALK+ tumour

• Research type

  Research Study

• Full title

  A phase I, multicenter, open-label dose escalation study of LDK378, administered orally in adult patients with tumors characterized by genetic abnormalities in anaplastic lymphoma kinase(ALK)

• IRAS ID

  64059

• Contact name

  Jeff Evans

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-019827-70

• ISRCTN Number

  NA

• Research summary

  This is a first-in-man study investigating the safety profile, optimal dose levels and how the body handles a new drug LDK378,in patients with a tumour confirmed to have genetic abnormalities in a protein called ALK.There will be two parts to the study, a dose escalation phase and an expansion phase. The dose escalation phase (where the dose of LDK378 will increase between groups of patients)will look at;- How the body handles and breaks down LDK378; where in the patient will be given a single dose of LDK378 on Day 1, followed by blood sample collections on Days 1 to 3 to analyse how much LDK378 is in the blood at various time-points. - How the body handles multiple doses of LDK378 to determine the optimal / safest dose level; On Day 4, patients will commence the treatment period in which LDK378 will be given continuously daily in 21 day cycles. Patients will continue to take LDK378 until discontinued due to; disease progression, appearance of unacceptable side effects, withdrawal by the Physician or patient refusal.Dose levels of LDK378 will vary between groups of patients as the study progresses. Dose levels of LDK378 will be increased if the first group of patients who take LDK378 tolerate the LDK378 dose well and their safety bloods are deemed normal. The dose of LDK378 will continue to increase until the maximum tolerated dose is determined.The expansion part of the study will commence after the maximum tolerated dose is determined in part 1 and will consist of 3 patient populations; ALK positive non small cell lung cancer (NSCLC) patients prior treatment with ALK inhibitors and ALK positive patients with any other tumour types other than NSCLC. Patients will receive the MTD of LDK378 continuously daily until discontinuation criteria is met (same as Part 1).

• REC name

  Scotland A REC

• REC reference

  10/MRE00/84

• Date of REC Opinion

  16 Dec 2010

• REC opinion

  Further Information Favourable Opinion