INNO-206 in Patients With Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00472771
• Other study ID #: INNO-206-P2
• Status: Withdrawn
• Phase: Phase 2
• First received: May 11, 2007
• Last updated: February 8, 2012
• Start date: May 2008
• Est. completion date: November 2008

Study information

• Verified date: February 2012
• Source: CytRx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.

Description:

This is a phase II, open-label, prospective, multicenter, single-arm study of INNO 206 in adult patients with recurrent extensive small cell lung cancer sensitive to first-line platinum-based therapy. The primary objective of the study is to determine the objective overall response rate. Secondary objectives include evaluating the treatment-related toxicities in this patient population and determining the pharmacokinetic (PK) profile of INNO-206 in a minimum of 12 patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be =18 years old.

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

• Have responded to first-line platinum-based chemotherapy, but progressed or relapsed =60 days after completion of first-line therapy.

• Have measurable disease defined by RECIST.

• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of =2.

• Have an estimated life expectancy of =4 weeks.

• Be male or non-pregnant, non-lactating female patients. Patients who are fertile must agree to use an effective barrier method of birth control to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication.

• 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).

• Have adequate organ function.

Exclusion Criteria:

• Are pregnant or lactating.

• Have received prior anthracycline therapy.

• Have participated in any investigational drug study within 30 days prior to study entry.

• Have received radiotherapy within 2 weeks of treatment in this study.

• Have not recovered from acute toxicity of all previous therapy prior to enrollment.

• 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 =6); or a history of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.

• Have symptomatic central nervous system (CNS) metastases.

• 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, etc.) 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.

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

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

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• INNO-206

Locations

Country	Name	City	State
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Billings Clinic	Billings	Montana
United States	University of Chicago	Chicago	Illinois
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Dayton Oncology and Hematology	Kettering	Ohio
United States	Signal Point Hematology/Oncology, Inc.	Middletown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
CytRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).
Secondary	To determine the rates of stable disease and progressive disease.
Secondary	To determine time to progression.
Secondary	To determine progression-free survival.
Secondary	To determine overall survival.
Secondary	To evaluate the treatment-related toxicities in this patient population.
Secondary	To determine the pharmacokinetic profile of INNO-206 in a minimum of 12 patients.