Know Cancer

or
forgot password

A Phase I, Multicenter, Open-label Dose Escalation Study of LDK378, Administered Orally in Japanese Patients With Tumors Characterized by Genetic Alterations in ALK


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Thank you

Trial Information

A Phase I, Multicenter, Open-label Dose Escalation Study of LDK378, Administered Orally in Japanese Patients With Tumors Characterized by Genetic Alterations in ALK


Inclusion Criteria:



- Patients with a locally advanced or metastatic malignancy that has progressed despite
standard therapy, or for which no effective standard therapy exists

- Only patients with tumors characterized by genetic alterations in ALK. For non-small
cell lung cancer (NSCLC), an ALK translocation must be detected by Fluorescent in
situ hybridization (FISH) in ≥15% of tumor cells. Local site documented results on
ALK alteration are acceptable for enrollment of the patients. Central confirmation of
local results is not required.

--Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2

- Adequate organ function

Exclusion Criteria:

- Patients with symptomatic Central Nerve System (CNS) metastases who are
neurologically unstable or require increasing doses of steroids to control their CNS
disease

- Patients with unresolved nausea, vomiting or diarrhea > Common Terminology Criteria
for Adverse Events (CTCAE) grade 1

- Other concurrent severe and/or uncontrolled medical conditions

- Patients who have been treated with chemotherapy or biologic therapy or other
investigational agent < 2 weeks prior to starting study drug for compounds with a
half-life ≤ 3 days, and < 4 weeks prior to starting study drug for compounds with a
prolonged half-life (< 6 weeks for patients that received nitrosoureas or
mitomycin-C)

- Unresolved toxicity greater than CTCAE grade 1 or unstable toxicity from previous
anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity,
lymphopenia), or incomplete recovery from previous surgery, unless agreed by Novartis
and the Principal Investigator and documented

- Patients who have received radiotherapy to a large volume (including whole brain
radiotherapy) < 2 weeks prior to starting study drug, and patients who have received
radiotherapy to a small volume (including stereotactic radiotherapy to the CNS) < 3
days prior to starting study drug.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378

Outcome Description:

As a single agent when administered orally to Japanese patients with tumors characterized by genetic alterations in ALK. The number of patients and category of Dose Limiting Toxicities (DLTs)

Outcome Time Frame:

During the first cycle (including the Pharmacokinetics [PK] run-in period) of LDK378 treatment. A treatment cycle consists of 21 days of daily dosing of LDK378.

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CLDK378X1101

NCT ID:

NCT01634763

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
  • Phase I, open-label, dose escalation, oral LDK378, Japanese patients with tumors characterized by ALK genetic alterations
  • Lymphoma

Name

Location