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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00975806
Other study ID # CC-5013-RCC-001
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date September 1, 2009
Est. completion date October 1, 2011

Study information

Verified date November 2019
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date October 1, 2011
Est. primary completion date October 1, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Metastatic Renal Cell Carcinoma.

2. Eastern Cooperative Oncology Group (ECOG) performance status of = 1.

Exclusion Criteria:

1. Prior chemotherapy.

2. Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib.

3. Laboratory values outside normal ranges.

4. Myocardial infarction (MI) within past 12 months.

5. Current congestive heart failure.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenalidomide
Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination
Sunitinib
Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G

Locations

Country Name City State
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Cleveland Clinic Main Campus Cleveland Ohio
United States Tennessee Oncology Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rini B, Redman B, Garcia JA, Burris HA 3rd, Li S, Fandi A, Beck R, Jungnelius U, Infante JR. A phase I/II study of lenalidomide in combination with sunitinib in patients with advanced or metastatic renal cell carcinoma. Ann Oncol. 2014 Sep;25(9):1794-9. d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1: Maximum Tolerated Dose (MTD) The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were:
• Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:
Grade (GR) 3 or 4 non-hematological toxicity lasting for = 14 days
Febrile neutropenia
Gr 4 neutropenia lasting for = 7 days
Gr 4 thrombocytopenia The occurrence of one of the above drug-related toxicities resulting in a clinical and/or laboratory assessment being done within 7 days following the initial finding to examine the participants for resolution of the toxicity. Lack of resolution of the toxicities was considered a DLT.
If = 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation.
Within 21 days of first dose of treatment
Primary Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:
Complete response-disappearance of all lesions
Partial response-30% decrease in the sum of diameters of target lesions from baseline
Stable disease-neither shrinkage nor increase of lesions.
Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.
After at least 3 cycles of treatment
Secondary Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively
Secondary Phase 1 : Tumor Response Rate According to RECIST 1.1 Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria:
Treatment response includes both complete response and partial response
Complete response-disappearance of all lesions
Partial response-30% decrease in the sum of diameters of target lesions from baseline
Stable disease-neither shrinkage nor increase of lesions
Progressive Disease-20% increase in the sum of diameters of target lesions from nadir
Every 3 cycles; up to month 25
Secondary Progression Free Survival (PFS) Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Day 1 of study drug to disease progression or death
Secondary Duration of Response Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR) Day 1 of initial response date to progressive disease
Secondary Overall Survival (OS) Overall survival was defined as the time from the start of study drug therapy to death. Day 1 of study drug to death
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