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A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest

Safety Issue:

Yes

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-ST-003

NCT ID:

NCT00046735

Start Date:

June 2002

Completion Date:

December 2009

Related Keywords:

  • Neoplasms
  • solid tumors
  • Revimid
  • CC5013
  • CC-5013
  • Neoplasms

Name

Location

Wake Forest UniversityWinston-Salem, North Carolina  27103