A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine (IMGN901) in Combination with Carboplatin/Etoposide in Patients with Advanced Solid Tumors including Extensive Stage Small Cell Lung Cancer - N/A

ImmunoGen, Inc0 sites181 target enrollmentAugust 1, 2011

ConditionsPhase 2: small cell lung cancer (extensive-stage disease)MedDRA version: 14.1 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10041058 Term: Small cell carcinoma of the lung System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Phase 2: small cell lung cancer (extensive-stage disease)
Sponsor: ImmunoGen, Inc
Enrollment: 181
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 1, 2011

End Date

May 12, 2015

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

ImmunoGen, Inc

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patients \=18 years old at the time of signing Informed Consent
•2\. Diagnosis
•Patients with histologically or cytologically confirmed SCLC and extensive disease as defined by the Veterans Administration Lung Cancer Group
•3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•4\. Prior therapy
•No prior systemic chemotherapy for the treatment of SCLC
•Previous radiotherapy, including cranial irradiation, is allowed if \< 30% of marrow\-bearing bones were irradiated and if radiotherapy was completed at least 7 days prior to enrollment and the patient has recovered or stabilized from all adverse effects of prior radiotherapy
•5\. Major surgery (this does not include placement of vascular access device or tumor biopsies) must be completed 4 weeks prior to Day 1
•6\. Patients must have at least one measurable lesion per RECIST 1\.1 guidelines for solid tumors.
•7\. Patients must have the following laboratory values:

Exclusion Criteria

•1\. Concurrently receiving other anti\-neoplastic treatment (e.g. chemotherapy, investigational therapy or immunotherapy including steroid therapy)
•2\. Grade \=2 neurotoxicity
•3\. Any serious medical condition including laboratory abnormalities, or psychiatric disorder that in the opinion of the Investigator places a patient at unacceptable risk if he/she were to participate in the study
•4\. Clinically relevant active infection including known active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, varicella\-zoster virus (shingles) or cytomegalovirus infection or any other known concurrent infectious disease which, in the judgment of the Investigator, would make a patient inappropriate for enrollment into this study
•5\. Significant cardiac disease such as recent myocardial infarction (\=6 months prior to Day 1\), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure \=180 mmHg or diastolic blood pressure \=110 mmHg ), uncontrolled cardiac arrhythmias, severe aortic stenosis, or \= grade 3 cardiac toxicity following prior chemotherapy
•6\. History of neurologic disease such as multiple sclerosis or other demyelinating disease; paraneoplastic neurologic syndrome such as Eaton\-Lambert syndrome, encephalomyelitis or sensory neuropathy;
•central nervous system (CNS) injury with residual neurological deficit; or has a history of hemorrhagic or ischemic stroke within the last 6 months
•7\. Patients with CNS metastases excluded unless previously treated with surgery or radiation and on stable, decreasing or no steroids. Patients with asymptomatic CNS metastases are eligible unless requiring steroids, anticonvulsants or other treatments to manage their CNS disease.
•8\. Patients with uncontrolled carcinoid syndrome (flushing, uncontrolled diarrhea, labile blood pressure)
•9\. Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids