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


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).

Principal Investigator

Michael Maitland, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

INNO-206-P2

NCT ID:

NCT00472771

Start Date:

May 2008

Completion Date:

November 2008

Related Keywords:

  • Small Cell Lung Cancer
  • Recurrent extensive small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Cancer Centers of the CarolinasGreenville, South Carolina  29605
Mary Crowley Medical Research CenterDallas, Texas  75246
New York Oncology Hematology, P.C.Albany, New York  12208
University of ChicagoChicago, Illinois  60637
Dayton Oncology and HematologyKettering, Ohio  
Billings ClinicBillings, Montana  59107-7000
Signal Point Hematology/Oncology, Inc.Middletown, Ohio  45042