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

December 7, 2021 updated by: Cyclacel Pharmaceuticals, Inc.

A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hematology Oncology Group
    • Florida
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernando Oncology
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaun Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Nevada Cancer Research Foundation
      • Reno, Nevada, United States, 89502
        • VA Sierra Nevada Health Care System
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants
    • New York
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburg Cancer Institute
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • The Family Cancer Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research and Treatment
      • Tyler, Texas, United States, 75701
        • East Texas Medical Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Hematology Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: over the course of the study
Time until the disease starts progressing
over the course of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyclacel Pharmaceuticals, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 9, 2006

Primary Completion (ACTUAL)

March 3, 2009

Study Completion (ACTUAL)

April 7, 2009

Study Registration Dates

First Submitted

September 3, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (ESTIMATE)

September 6, 2006

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYC202-06-14 (A1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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