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Renal Cell CarcinomaPhase 1/2NCT00975806

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

A Phase 1/2 study testing Lenalidomide and Sunitinib in people with Renal Cell Carcinoma, run by Celgene at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Lenalidomide and Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
3 sitesUnited States
Study dates
1 Sep 2009to 1 Oct 2011
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • Tennessee Oncology

    Nashville, Tennessee, 37203

Other trials in United States

About this study

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

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.

Being tested
Lenalidomide, Sunitinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called CC-5013, Revlimid

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

  • SunitinibDrug

    Also called Sutent

    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

Study groups in NCT00975806
Study groupRoleWhat they receive
Cohort AExperimentalParticipants 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
Receives: Drug: Lenalidomide; Drug: Sunitinib
Cohorts F and GExperimentalParticipants 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
Receives: Drug: Lenalidomide; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 21 days of first dose of treatment

  2. 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.

    Measured: After at least 3 cycles of treatment

Secondary outcomes (5)

  1. 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

    Measured: 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

  2. 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

    Measured: Every 3 cycles; up to month 25

  3. 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.

    Measured: Day 1 of study drug to disease progression or death

  4. 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)

    Measured: Day 1 of initial response date to progressive disease

  5. Overall Survival (OS)

    Overall survival was defined as the time from the start of study drug therapy to death.

    Measured: Day 1 of study drug to death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2009 (estimated)
  2. Study start1 Sep 2009
  3. Primary completion1 Oct 2011
  4. Study completion1 Oct 2011

Why it stopped: MTD determined sub-optimal as efficacious treatment for renal cell carcinoma.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00975806
Sponsor's protocol ID
CC-5013-RCC-001
Status last verified
Nov 2019
First submitted
9 Sep 2009
Last updated
25 Nov 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 24914044

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide and Sunitinib in people with Renal Cell Carcinoma, run by Celgene at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Maximum Tolerated Dose (MTD) (time frame: Within 21 days of first dose of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00975806, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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