A Phase II, Open-label Study of INNO-206 in Patients with Recurrent Extensive Small Cell Lung Cancer after First-line Platinum-based Therapy

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10041067Term: Small cell lung cancer; Recurrent extensive small cell lung cancer after first-line platinum-based therapy.

• Registration Number: EUCTR2006-005514-12-DE
• Lead Sponsor: INNOVIVE Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients must meet all of the following criteria for admission into the study:

(1) Informed consent must be obtained in writing for all patients prior to enrollment into the study.

(2) Be greater than or equal to 18 years old. In Germany, patients must be less than or equal to 70 years old when consent is obtained.

(3) Have a histologically or cytologically confirmed diagnosis of recurrent extensive small cell lung cancer (SCLC) at time of enrollment into the study.

(4) Have responded to first-line platinum-based chemotherapy, but progressed or relapsed greater than or equal to 60 days after completion of first-line therapy.

(5) Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

(6) Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.

(7) Have an estimated life expectancy of greater than or equal to 4 weeks.

(8) Be male or non-pregnant, non-lactating female patients. For US patients who are fertile, they must agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication. For all non-US patients, who are fertile, they must agree to use two forms of barrier method contraception (e.g., latex condom AND a diaphragm or cervical cap) while on therapy and for 90 days following the discontinuation of the study medication.
A non-fertile female is defined as:
-- Postmenopausal (amenorrheic for greater than or equal to 12 months)
-- Undergone a complete oopherectomy and hysterectomy

(9) Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study medication (if patient is a female of childbearing potential).

(10) Have adequate organ function as indicated by the laboratory values specified in the protocol obtained within 14 days prior to the first dose of study drug.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study admission:

(1) Are pregnant, lactating, or had childbirth within 6 months prior to study entry.

(2) Have received prior anthracycline therapy.

(3) Have participated in any investigational drug study within 30 days prior to study entry.

(4) Have received radiotherapy within 2 weeks (14 days) of treatment in this study.

(5) Have not recovered from acute toxicity of all previous therapy prior to enrollment.

(6) Have a history of a malignancy other than SCLC; exceptions to this include:
-- Curatively treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix; or prior low-grade, localized prostate cancer (Gleason score less than or equal to 6).
-- History of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.

(7) Have symptomatic central nervous system (CNS) metastases.

(8) Have any concurrent severe or uncontrolled medical disease (such as active systemic infection, hypertension, congestive heart failure =NYHA Grade II, myocardial infarction within 6 months before study start, severe rhythm disturbances including arrhythmias with negative hemodynamic effects, acute inflammatory heart disease) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.

(9) Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.

(10) Have received radiotherapy with >25% involvement of the bone marrow within 6 weeks prior to study start.

(11) Have a known hypersensitivity to doxorubicin, other anthracyclines, 5% D-(+)-sucrose, 10 mM sodium phosphate, and/or 0.3% N acetyltryptophane.

(12) In Germany, the following exclusion criteria also apply:
a. Have hemorrhagic diathesim,
b. Have active stomatides,
c. Have active generalized infection,
d. Have distinct myelosuppression (for example after previous radiotherapy or chemotherapy), or
e. Have severe liver dysfunction.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the objective overall response rate (complete plus partial responses).;Secondary Objective: • To determine the rates of stable disease (SD) and progressive disease (PD).<br>• To determine time to progression (TTP).<br>• To determine progression-free survival (PFS).<br>• To determine overall survival (OS).<br>• To evaluate the treatment-related toxicities in this patient population.<br>• To determine the pharmacokinetic (PK) profile of INNO-206 in a minimum of 12 patients.;Primary end point(s): Complete and partial disease responses will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST).