Phase II Study of ADI-PEG 20 in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer

Phase 1

Conditions: Relapsed Sensitive or Refractory Small Cell Lung Cancer
MedDRA version: 14.1Level: PTClassification code 10041070Term: Small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-017885-22-BE

Lead Sponsor: udwig Institute for Cancer Research, Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

1) Patients must have histologically documented small cell lung cancer (SCLC).
2) Eligible patients are assigned to one of two cohorts based on the following characteristics:
Cohort 1: Sensitive” disease patients who had one previous line of chemotherapy and maintained an appropriate response for 90 days or more or Cohort 2: (a) refractory” disease patients, who had one previous line of chemotherapy and either had no response or progressed in less than 90 days after completing treatment or (b) any patient (sensitive” or refractory”) in need of 3rd line therapy, i.e., who completed or failed two previous lines of chemotherapy.
3) Measurable disease using RECIST v 1.1 criteria.
4) ASS tumor expression must be either negative or < 5% + tumor cells (by IHC analysis, for details, see Section 8.7.1 on page 45).
5) Karnofsky performance status of 60% or more.
6) 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 (see protocol)
7) Age = 18 years.
8) Able and willing to give valid written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 restricted according to Section 5.3.
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

Primary Outcome Measures

Name	Time	Method
Main Objective: Clinical Efficacy (tumor response);Secondary Objective: Safety and Tolerability<br>Pharmacodynamics (plasma arginine and citrulline levels)<br>Immunogenicity (ADI-PEG 20 antibodies)<br>Clinical Efficacy (overall survival)<br>;Primary end point(s): The primary endpoint for clinical efficacy is the tumor response defined as CR or PR, assessed in accordance with the established RECIST 1.1 methods and criteria (52);Timepoint(s) of evaluation of this end point: every 4 to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Subjects who received at least one dose of ADI-PEG 20, as well as, baseline and at least one post-baseline imunogenicity assessment, will be included in this analysis. In order to investigate patterns in the levels of anti-ADI-PEG 20 antibody over time, mixed models methods or (if the limited sample size does not render this analysis feasible) repeated measures Anova method will be used. Overall survival (OS) will be measured from the initial date of treatment to the recorded date of death. ;Timepoint(s) of evaluation of this end point: Peripheral blood ADI-PEG 20 antibodies will be determined weekly in Cycle 1-2 and every 4 weeks in Cycle 3-4. ELISA assays will be performed by Polaris Pharmaceuticals, Inc. and St Bartholomew's Hospital. The outcome will be measured on a continuous scale

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