Trial Search Results

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

This is a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment will be assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above is not locally available, a test to confirm ALK rearrangement must be performed by a Novartis designated central laboratory. Patients must wait for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Intervention(s):

  • Drug: LDK378

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Histologically or cytologically confirmed diagnosis of metastatic NSCLC according to
   the 7th edition of the AJCC Cancer Staging Manual. In addition, the NSCLC must harbor
   an ALK rearrangement, as assessed using the FDA approved Vysis ALK Break Apart FISH
   Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity
   criteria). If documentation of ALK rearrangement as described above is not locally
   available, a test to confirm ALK rearrangement must be performed by a Novartis
   designated central laboratory. Patients must wait for the central laboratory result of
   the ALK rearrangement status before initiating treatment with ceritinib

   - At least one extracranial measurable lesion as defined by RECIST 1.1. A previously
   irradiated site lesion may only be counted as a target lesion if there is clear sign
   of progression since the irradiation.

   - Patients may or may not have neurological symptoms but must be able to swallow and
   retain oral medication. Be neurologically stable within at least 1 week prior to the
   first dose of study drug.

   - Patients may have received prior chemotherapy, crizotinib (other ALK inhibitors are
   not allowed), biologic therapy or other investigational agents. Patients must have
   recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
   (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.

   - Patient has life expectancy ≥ 6 weeks.

   - Patient has a WHO performance status 0-2.

Patients in Arm 1 to 4 must also meet the following inclusion criteria:

- Patients must have active brain metastases from NSCLC, confirmed by Gadolinium-enhanced
MRI without concomitant leptomeningeal carcinomatosis. Dose of steroids must be stable for
5 days before the baseline brain MRI.

Patients in Arm 5 must also meet the following inclusion criteria:

- Patients must be diagnosed with leptomeningeal carcinomatosis.

Exclusion Criteria:

   - Patients who need whole brain radiation to control the brain metastases. Patients will
   not be eligible unless treated brain lesions are progressive or new brain lesions are
   observed since the post whole brain radiation therapy MRI.

   - Planning of any brain local treatment (including but not limited to surgery,
   stereotactic radiosurgery, whole brain radiation, intrathecal chemotherapy) following
   the administration of the first dose of study drug.

   - Patient with a concurrent malignancy or history of a malignant disease other than
   NSCLC that has been diagnosed and/or required therapy within the past 3 years.
   Exceptions to this exclusion include the following: completely resected basal cell and
   squamous cell skin cancers, and completely resected carcinoma in situ of any type.

   - Patient has impairment of GI function or GI disease that may significantly alter the
   absorption of ceritinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting,
   diarrhea, or malabsorption syndrome).

   - Patient is receiving unstable or increasing doses of corticosteroids.

   - Patient has other severe, acute, or chronic medical conditions including uncontrolled
   diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the
   opinion of the investigator may increase the risk associated with study participation,
   or that may interfere with the interpretation of study results.

Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting