Phase II clinical trial exploring the activity of crizotinib in patients with advanced solid tumors induced by causal alterations of specific receptors (ALK and MET/HGF receptor tyrosine kinases) expressed by cancer cells

Phase 1

• Conditions: MedDRA version: 14.1Level: PTClassification code 10001882Term: Alveolar soft part sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10067918Term: Inflammatory myofibroblastic tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; ocally advanced and/or metastatic malignant tumor (anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, papillary renal cell carcinoma type 1, alveolar soft part sarcoma, clear cell sarcoma or alveolar rhabdomyosarcoma) deemed incurable by conventional surgery, radiotherapy, systemic therapy or any other means.; MedDRA version: 14.1Level: PTClassification code 10002227Term: Anaplastic large cell lymphoma T- and null-cell typesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10065865Term: Clear cell sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-001988-52-AT
• Lead Sponsor: EORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-19
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 582

Inclusion Criteria

Step 1 registration:
• Local diagnosis of locally advanced and/or metastatic malignant tumor (defined before) deemed incurable by conventional surgery, radiotherapy, systemic therapy or any other means.
• Mandatory shipment of tumor-containing tissue blocks.
Step 2 registration:
• Measurable disease according to RECIST 1.1 with target lesion of at least 20 mm (or 10 mm on spiral CT scans).
• Minimum age 15 years, no upper age limit.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate hematological function: ANC = 1 x 109/L, platelets = 30 x 109/L and hemoglobin = 8 g/dl.
• Adequate renal function: serum creatinine = 2 x ULN.
• Adequate liver function: Bilirubin = 1.5 x ULN. AST and ALT = 2.5 x ULN in the absence of liver metastases and = 5 x UNL if liver function abnormalities are due to the underlying malignancy.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• Negative pregnancy test
• All patients (male and female) of childbearing/reproductive potential must use adequate birth control measures during the study treatment period and for at least three months after the last study treatment
• Written consent before registration
Additional inclusion criteria linked to specific tumor type are described in the protocol in section 3.2.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

Step 2 registration:
• Carcinomatous meningitis or leptomeningeal disease.
• Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug before treatment with crizotinib (whatever is the longest period).
• Prior therapy directly targeting ALK and/or MET, previous treatment with crizotinib.
• Previous and active malignancy for the last three years with the exception of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma.
• Acute or chronic severe gastrointestinal conditions such as diarrhea or ulcer.
• Current congestive heart failure.
• Ongoing cardiac dysrhythmias of NCI CTCAE Grade >2.
• Uncontrolled atrial fibrillation of any grade.
• Pregnant women

Study & Design

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