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

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
seliciclib
placebo
Sponsored by
Cyclacel Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Cancer Center
  • Pacific Coast Hematology Oncology Group
  • Pasco Hernando Oncology
  • Rush University Medical Center
  • The University of Chicago
  • University of Maryland, Greenebaun Cancer Center
  • Dana Farber Cancer Institute
  • Nebraska Medical Center
  • Nevada Cancer Research Foundation
  • VA Sierra Nevada Health Care System
  • New Mexico Oncology Hematology Consultants
  • Columbia Presbyterian Medical Center
  • Penn State Milton S. Hershey Medical Center
  • University of Pittsburg Cancer Institute
  • The Family Cancer Center
  • Vanderbilt University Medical Center
  • Southwest Regional Cancer Center
  • Center for Oncology Research and Treatment
  • East Texas Medical Center
  • Danville Hematology Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1 with seliciclib

Arm 2 with placebo control

Arm Description

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.

Randomized to placebo after run-in period.

Outcomes

Primary Outcome Measures

Progression-free survival
Time until the disease starts progressing

Secondary Outcome Measures

Full Information

First Posted
September 3, 2006
Last Updated
December 7, 2021
Sponsor
Cyclacel Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00372073
Brief Title
Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
Official Title
A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Study Start Date
August 9, 2006 (Actual)
Primary Completion Date
March 3, 2009 (Actual)
Study Completion Date
April 7, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclacel Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 with seliciclib
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 2 with placebo control
Arm Type
Placebo Comparator
Arm Description
Randomized to placebo after run-in period.
Intervention Type
Drug
Intervention Name(s)
seliciclib
Other Intervention Name(s)
CYC202
Intervention Description
1200 mg bid x 3 days every 2 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1200 mg bid x 3 days every 2 weeks
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Time until the disease starts progressing
Time Frame
over the course of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandra Belani, M.D.
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Pacific Coast Hematology Oncology Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pasco Hernando Oncology
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Maryland, Greenebaun Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pittsburg Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
The Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Center for Oncology Research and Treatment
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
East Texas Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Danville Hematology Oncology
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19238148
Citation
Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
Results Reference
derived

Learn more about this trial

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

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