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

This study has been terminated.
(MTD determined sub-optimal as efficacious treatment for renal cell carcinoma.)
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier:
NCT00975806
First received: September 9, 2009
Last updated: February 3, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention Phase
Renal Cell Carcinoma
Drug: Lenalidomide (CC-5013) in combination with sunitinib
Drug: Lenalidomide
Drug: Sunitinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Phase 1: Maximum Tolerated Dose (MTD) [ Time Frame: Within 21 days of first dose of treatment ] [ Designated as safety issue: Yes ]

    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.


  • Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) [ Time Frame: After at least 3 cycles of treatment ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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

  • Phase 1 : Tumor Response Rate According to RECIST 1.1 [ Time Frame: Every 3 cycles; up to month 25 ] [ Designated as safety issue: No ]

    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

  • Progression Free Survival (PFS) [ Time Frame: Day 1 of study drug to disease progression or death ] [ Designated as safety issue: No ]
    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.

  • Duration of Response [ Time Frame: Day 1 of initial response date to progressive disease ] [ Designated as safety issue: No ]
    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)

  • Overall Survival (OS) [ Time Frame: Day 1 of study drug to death ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the start of study drug therapy to death.


Enrollment: 16
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide and oral sunitinib
Participants received a single oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib on Days 1 to 14 or Days 1 to 21 of each 21 day cycle
Drug: Lenalidomide (CC-5013) in combination with sunitinib
Lenalidomide MTD mg daily for Days 1- 21 in combination with sunitinib 37.5 mg daily for Days 1-21 of a 21 day cycle until disease progression
Drug: Lenalidomide
Other Names:
  • CC-5013
  • Revlimid
Drug: Sunitinib
Other Name: Sutent

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975806

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Debora Barton, MD Celgene Corporation
  More Information

Publications:
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00975806     History of Changes
Other Study ID Numbers: CC-5013-RCC-001 
Study First Received: September 9, 2009
Results First Received: December 17, 2014
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lenalidomide
Thalidomide
Sunitinib
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016