Working… Menu
Trial record 10 of 24 for:    inno-206

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472771
Recruitment Status : Withdrawn (Terminated due to clinical trial material production delays)
First Posted : May 14, 2007
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: INNO-206 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00472771

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Michael Maitland, MD University of Chicago
Layout table for additonal information
Responsible Party: CytRx Identifier: NCT00472771    
Other Study ID Numbers: INNO-206-P2
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012
Keywords provided by CytRx:
Recurrent extensive small cell lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms