A clinical study evaluating ceritinib in tumors with ALK genetic abnormalities

Phase 1

• Conditions: Advanced solid tumors and hematological malignancies with ALK genetic alteration and/or overexpression; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000814-23-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-26
• Last Update Posted: 3 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

- Written informed consent for the main study obtained prior to any screening procedure.
- Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for ALK testing at a Novartis designated central laboratory by a comparative technology: the confirmation of ALK positivity is not required for enrollment if other inclusion and exclusion criteria are fulfilled
- Patient is 18 years or older at the time of informed consent.
- Patient has WHO performance status = 2.
- Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation

Other protocol related inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

1. Patient with ALK+ lung cancer.
2. Patient with known hypersensitivity to any of the excipients of LDK378.
3. Patient with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
4. History of carcinomatous meningitis.
5. Patient with diarrhea CTCAE = grade 2; or patients with neuropathy CTCAE = grade 2

Other protocol related exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified