Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00975806
• Other study ID #: CC-5013-RCC-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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