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

NCT00975806 | Terminated Phase 1 Results

• 1 other identifier: CC-5013-RCC-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib

  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

• Phase 1 : Tumor Response Rate According to RECIST 1.1

  Every 3 cycles; up to month 25

• Progression Free Survival (PFS)

  Day 1 of study drug to disease progression or death

• Duration of Response

  Day 1 of initial response date to progressive disease

• Overall Survival (OS)

  Day 1 of study drug to death

Study Arms (2)

Cohort A

EXPERIMENTAL

Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle

Drug: Lenalidomide; Drug: Sunitinib

Cohorts F and G

EXPERIMENTAL

Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle

Drug: Lenalidomide; Drug: Sunitinib

Interventions

Lenalidomide DRUG

Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination

Also known as: CC-5013, Revlimid

Cohort A; Cohorts F and G

Sunitinib DRUG

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

Also known as: Sutent

Cohort A; Cohorts F and G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic Renal Cell Carcinoma.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

You may not qualify if:

• Prior chemotherapy.
• Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib.
• Laboratory values outside normal ranges.
• Myocardial infarction (MI) within past 12 months.
• Current congestive heart failure.

Sponsors & Collaborators

• Celgene: lead

Study Sites (3)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Related 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):1794-1799. doi: 10.1093/annonc/mdu212. Epub 2014 Jun 8.

  PMID: 24914044 RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Lenalidomide; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Indoles

Results Point of Contact

• Title: Anne McClain,Senior Manager
• Organization: Celgene Corporation

clinicaltrialsdisclosure@celgene.com

1-888-260-1599

Study Officials

• Debora Barton, MD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 11, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 25, 2019
• Results First Posted: December 29, 2014

Record last verified: 2019-11

Locations

US (3)