Phase 1 Study OF CDC-501 in Patients With Solid Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Celgene Corporation.
Recruitment status was Active, not recruiting
Information provided by:
First received: October 2, 2002
Last updated: September 30, 2009
Last verified: September 2009
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.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||August 2006 (Final data collection date for primary outcome measure)
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
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patient must understand and voluntarily sign an informed consent document.
- Age 18 years at the time of signing Informed Consent
- Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
- Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
- Patient has an ECOG (Zubrod) performance status of ≤ 2.
- Approximate life expectancy greater than 3 months.
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
- The following prior treatments are allowable under this protocol:
- 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
- Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
- Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
- Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
- 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).
- Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
- Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
- Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
- CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
- 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.
- Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00046735
|Wake Forest University
|Winston-Salem, North Carolina, United States, 27157 |
||Robert Knight, MD
No publications provided
||Robert Knight, VP Hematology, Celgene Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 2, 2002
||September 30, 2009
||United States: Food and Drug Administration
Keywords provided by Celgene Corporation:
ClinicalTrials.gov processed this record on March 25, 2015