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Phase 1 Study OF CDC-501 in Patients With Solid Tumors

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.
 
ClinicalTrials.gov Identifier: NCT00046735
Recruitment Status : Completed
First Posted : October 3, 2002
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Lenalidomide Phase 1

Detailed Description:
Identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors
Actual Study Start Date : June 1, 2002
Actual Primary Completion Date : August 1, 2006
Actual Study Completion Date : September 28, 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: Lenalidomide
The planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT




Primary Outcome Measures :
  1. To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment. [ Time Frame: 6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient must understand and voluntarily sign an informed consent document.
  2. Age 18 years at the time of signing Informed Consent
  3. Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
  4. Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
  5. Patient has an ECOG (Zubrod) performance status of ≤ 2.
  6. Approximate life expectancy greater than 3 months.
  7. Laboratory tests within these ranges:

    • Absolute neutrophil count ≥ 1,500/μlL
    • Platelet count ≥100,000/μL
    • Serum creatinine ≤1.5 mg/dL
    • Total bilirubin ≤1.5 mg/dL
    • AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases present
  8. The following prior treatments are allowable under this protocol:
  9. Radiation, if discontinued at least 4 weeks prior to treatment under this protocol Chemotherapy, if discontinued at least 4 weeks prior to treatment under this protocol, and at least 6 weeks prior to treatment under this protocol for prior nitrosurea or mitomycin-C treatment
  10. Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
  11. Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
  12. Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
  13. Patient must be able to adhere to the study visit schedule and other protocol requirements.
  14. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion Criteria

  1. Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
  2. Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
  3. Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
  4. CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
  5. Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
  6. Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
  7. Any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.

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 ClinicalTrials.gov identifier (NCT number): NCT00046735


Locations
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United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Robert Knight, MD Celgene Corporation
Publications:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00046735    
Other Study ID Numbers: CC-5013-ST-003
First Posted: October 3, 2002    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Keywords provided by Celgene:
solid tumors
Revimid
CC5013
CC-5013
Additional relevant MeSH terms:
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Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents