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Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer

Sponsor
Cyclacel Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00372073
Collaborator
(none)
187
Enrollment
20
Locations
2
Arms
31.9
Actual Duration (Months)
9.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

A randomized Phase II study of an experimental anti-cancer drug called seliciclib with objectives of evaluating safety and efficacy in patients with non-small cell lung cancer.

Study Design

Study Type:
Interventional
Actual Enrollment :
187 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
Actual Study Start Date :
Aug 9, 2006
Actual Primary Completion Date :
Mar 3, 2009
Actual Study Completion Date :
Apr 7, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1 with seliciclib

Oral seliciclib at 1200mg b.i.d. for 3 consecutive days as an outpatient beginning on day 1 every 2 weeks for 3 cycles as run-in. Patients (randomized) continue on treatment if derived clinical benefit during run-in period.

Drug: seliciclib
1200 mg bid x 3 days every 2 weeks
Other Names:
  • CYC202

    		•
    Placebo Comparator: Arm 2 with placebo control

    Randomized to placebo after run-in period.

    Drug: placebo
    1200 mg bid x 3 days every 2 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [over the course of the study]

      Time until the disease starts progressing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens

    • Must have measurable disease according to RECIST

    • Eastern Cooperative Oncology Group performance status 0-1

    • Adequate bone marrow, hepatic and renal function

    • Ability to swallow capsules

    • At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, at least 7 days from prior radiation therapy and have recovered from prior toxicities

    • At least 3 weeks from major surgery

    Exclusion Criteria:

    • Non-small cell cancer histology contains a component of small cell lung cancer

    • Previously untreated CNS metastasis or progressive CNS metastasis

    • Prior treatment with a CDK inhibitor

    • Currently receiving radiotherapy, biological therapy, or any other investigational therapy

    • Uncontrolled intercurrent illness

    • Having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer

    • Pregnant or lactating women

    • Known to be HIV-positive

    • Active hepatitis B and/or hepatitis C infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724
    2 Pacific Coast Hematology Oncology Group Fountain Valley California United States 92708
    3 Pasco Hernando Oncology New Port Richey Florida United States 34652
    4 Rush University Medical Center Chicago Illinois United States 60612
    5 The University of Chicago Chicago Illinois United States 60637
    6 University of Maryland, Greenebaun Cancer Center Baltimore Maryland United States 21201
    7 Dana Farber Cancer Institute Boston Massachusetts United States 02115
    8 Nebraska Medical Center Omaha Nebraska United States 68198
    9 Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    10 VA Sierra Nevada Health Care System Reno Nevada United States 89502
    11 New Mexico Oncology Hematology Consultants Albuquerque New Mexico United States 87109
    12 Columbia Presbyterian Medical Center New York New York United States 10032
    13 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    14 University of Pittsburg Cancer Institute Pittsburgh Pennsylvania United States 15232
    15 The Family Cancer Center Collierville Tennessee United States 38017
    16 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    17 Southwest Regional Cancer Center Austin Texas United States 78705
    18 Center for Oncology Research and Treatment Dallas Texas United States 75230
    19 East Texas Medical Center Tyler Texas United States 75701
    20 Danville Hematology Oncology Danville Virginia United States 24541

    Sponsors and Collaborators

    • Cyclacel Pharmaceuticals, Inc.

    Investigators

    • Study Chair: Chandra Belani, M.D., Milton S. Hershey Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cyclacel Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT00372073
    Other Study ID Numbers:
    • CYC202-06-14 (A1)
    First Posted:
    Sep 6, 2006
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Roscovitine

    Study Results

    No Results Posted as of Dec 22, 2021