ADI-PEG 20 in patients with relapsed sensitive or refractory small cell lung cancer

Phase 1

• Conditions: Small Cell Lung Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-017885-22-GB
• Lead Sponsor: udwig Institute For Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1)Patients must have histologically documented small cell lung cancer (SCLC) • Sensitive disease patients who maintain an appropriate response to 1st line chemotherapy for 3 months or more (Group 1) or • Refractory disease patients who either had no response to 1st line chemotherapy, or progressed within 3 months after completing 1st line chemotherapy treatment (Group 2) or • Patients (sensitive or refractory) who have completed or failed 2nd line chemotherapy (Group 2) 2)Measurable disease using RECIST criteria. 3)ASS tumour expression must be either negative or <5% + tumor cells (by IHC analysis) 4)Karnofsky performance status of 60% or more. 5)Laboratory parameters for vital functions should be in the normal range. Laboratory abnormalities that are not clinically significant are generally permitted, except for the following laboratory parameters, which must be within the ranges specified: Neutrophil count = 1.5 x 109/L Lymphocyte count = 0.5 x 109/L Platelet count = 50 x 109/L Serum creatinine = 1.5 ULN (or CrCl =60mL/min) Serum bilirubin = 2mg/dL (or =34 µmol/L) Serum uric acid = 8mg/dL (or = 0.48 mmol/L) 6)Age =18 years. 7)Able and willing to give valid written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1)Subjects previously treated with ADI-PEG 20. 2)Known allergy to pegylated products. 3)History of uncontrolled seizure. 4)Serious illnesses e.g. serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would interfere with the ability of the patient to fulfill the study requirements. 5)Metastatic disease to the central nervous system, unless treated and stable. 6)Known immunodeficiency or HIV positivity. 7)Participation in any other clinical trial involving another investigational agent within 3 weeks prior to first dosing of study agent. 8)Any other malignancy that requires concomitant therapy that is restricted as per protocol. 9)Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 10)Lack of availability for clinical follow-up assessment. 11)Pregnancy or breast feeding. 12)Refusal or inability to use effective means of contraception for men and women of childbearing potential for the duration of the study.

Study & Design

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