Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase Translocation

NCT01637597 | Unknown

• 1 other identifier: 201204080RIC
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory study in patients with locally advanced or metastatic Non-small cell lung cancer. Patients who are eligible to apply for Extended Access Program of crizotinib must have ALK translocation detected by RT-PCR, IHC or FISH analyses methods.

Conditions

Non-small Cell Lung Cancer(NSCLC)

Keywords

Non-small cell lung cancer(NSCLC)

Outcome Measures

Primary Outcomes (1)

• Overall response rate in patients with positive ALK determined from different molecular analysis methods.

  It is defined as the time from day 1 of crizotinib to disease progression or patient's death.

Secondary Outcomes (2)

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  1 year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced or metastatic NSCLC who are eligible to apply for Extended Access Program of crizotinib must have ALK translocation detected by RT-PCR, IHC or FISH analyses methods.

You may qualify if:

• Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by RT-PCR or IHC (5A4, 3+ score). Patients must have failed and progressed through at least one line of platinum containing chemotherapy or failed and progressed through chemotherapy if they were older than 70 years old.
• Patient must have at least one measurable lesion.
• Patient is male or female and ≥ 20 years of age on the day of signing informed consent.
• Patient must have performance status ≤ 2 on the ECOG Performance Scale.
• Patient must have adequate organ function as indicated by the following laboratory values: adequate liver (total bilirubin \< 1.5 x the upper limit of normal (ULN), total bilirubin \> 1.5 x ULN but biliary obstruction is documented radiologically, transaminases \< 2.5 x ULN or \< 5 x ULN if due to liver metastases), renal (creatinine \< 2 x ULN) and bone marrow function (hemoglobin \> 8g/dL, absolute neutrophil count \> 1 X 109/L and platelets \> 30 X 109/L)
• Female patient of childbearing potential has a negative serum or urine pregnancy test β-hCG within 5 days prior to receiving the first dose of study medication.
• Patients have completed chemotherapy regimens have residual toxicity \< Grade 1 except alopecia.
• Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent.
• Patient is able to swallow capsules and has no surgical or anatomical condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis.

You may not qualify if:

• Patient who has had chemotherapy within 2 weeks prior to Day 1 of Cycle 1 or has not recovered from the adverse events due to previous agents prior to Day 1 of Cycle 1. If the patient has residual toxicity from prior treatment, toxicity must be ≤ Grade 1 except alopecia.
• Patient who has had major surgery within 4 weeks prior to starting of treatment or expect major surgery in the study duration. Patient who has had prior radiotherapy (except brain) within 1 week prior to Day 1 of Cycle 1.
• Patient is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5x half-life from prior agents, whichever is longer, of Day 1 of this study.
• Patient has known active CNS metastases and/or carcinomatous meningitis unless patients were clinically stable for 2 weeks after radiotherapy.
• Patient with a primary central nervous system tumor.
• Patient has known hypersensitivity to the components of study drug or its analogs.
• Patient has severe systemic disease.
• Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
• Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
• Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
• Patient is known to be Human Immunodeficiency Virus (HIV)-positive
• Patient currently has active Hepatitis B which is defined as patient has positive serum HBsAg with ALT \> 2 x ULN and HBV DNA \> 20,000 IU/mL.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (2)

• Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.

  PMID: 27130468 DERIVED

• Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326.

  PMID: 25436806 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tumor tissue are being collected during the course of this study, to assess the safety and tolerability and spectrum of side effects of the study drug. However, it is possible that after completion of all study-related analyses, some volume of samples may remain. These left-over samples could be a valuable resource for future research. Before any left-over samples can be used for any research other than that specified in the protocol, patient must sign an additional future use consent from indicating they give their permission for these samples to be used in future research. By signing the main consent form, patients are only giving their permission to use their samples for the study related procedures.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• James Chih-Hsin Yang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 11, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

TW (1)