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

This study has been withdrawn prior to enrollment.
(Terminated due to clinical trial material production delays)
Sponsor:
Information provided by (Responsible Party):
CytRx
ClinicalTrials.gov Identifier:
NCT00472771
First received: May 11, 2007
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Small Cell Lung Cancer
Drug: INNO-206
Phase 2

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

Resource links provided by NLM:


Further study details as provided by CytRx:

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

Secondary Outcome Measures:
  • To determine the rates of stable disease and progressive disease.
  • To determine time to progression.
  • To determine progression-free survival.
  • To determine overall survival.
  • To evaluate the treatment-related toxicities in this patient population.
  • To determine the pharmacokinetic profile of INNO-206 in a minimum of 12 patients.

Enrollment: 0
Study Start Date: May 2008
Study Completion Date: November 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472771

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
United States, Ohio
Dayton Oncology and Hematology
Kettering, Ohio, United States, 45409
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, United States, 45042
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
CytRx
Investigators
Principal Investigator: Michael Maitland, MD University of Chicago
  More Information

No publications provided

Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT00472771     History of Changes
Other Study ID Numbers: INNO-206-P2
Study First Received: May 11, 2007
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CytRx:
Recurrent extensive small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on August 27, 2014