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Solid Organ MalignanciesPhase 1NCT01218555

Study of Everolimus (RAD001) in Combination With Lenalidomide

A Phase 1 study testing Lenalidomide and Everolimus in people with Solid Organ Malignancies and Adenoidcystic Carcinoma, run by Emory University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to study the combination of two anticancer drugs, everolimus (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard treatment or patients who are unable to tolerate the standard treatment for their cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenalidomide and Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesUnited States
Study dates
9 Sep 2010to 5 Nov 2020
Phase
Phase 1
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

  • Subjects must meet the following inclusion/exclusion criteria to be eligible for the study.
  • Ability to understand and willingness to voluntarily sign an informed consent form.
  • Histologic or cytologic confirmation of a solid malignancy.
  • Age ≥ 18 years at the time of signing the informed consent form. Because no dosing or adverse event data are currently available on the use of everolimus in combination with lenalidomide in patients < 18 years of age, children are excluded from this study.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Patients must have at least one measurable site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
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  • Diagnosed with advanced refractory solid malignancies or intolerant of standard therapy for the stage of the disease (because there is currently no standard approved therapy for adenoidcystic carcinoma, therefore there is no requirement of prior therapy for this patient population).
  • All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study. A minimum of 6 weeks treatment break is required in case of nitrosoureas or mitomycin C.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 at study entry.
  • Able to receive prophylactic anticoagulation with aspirin, warfarin or low molecular weight heparin when required for lenalidomide administration.
  • Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x upper limit of normal (ULN). NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
  • Laboratory test results within these ranges:
  • Absolute neutrophil count 1500 ≥ /mm³
  • Platelet count ≥ 100,000/mm³
  • Hb ≥ 9 g/dL
  • Creatinine within institutional limits of normal or creatinine clearance ≥ 60 ml/min/m² if elevated creatinine
  • Total bilirubin < 2.0 mg/dL or < 1.5.0 x ULN for the institution whichever is higher
  • Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) < 2.x ULN or < 5 x ULN if hepatic metastases are present.
  • All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS®) program, and be willing and able to comply with the requirements of the REMS® program.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International Unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.

Who cannot join

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements including signing the informed consent form.
  • Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Known hypersensitivity to thalidomide or everolimus (including other rapamycins, sirolimus and temsirolimus).
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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  • Prior treatment with lenalidomide or everolimus.
  • Concurrent use of other anti-cancer agents or treatments.
  • Patients known to be positive for HIV or infectious hepatitis, type B or C requiring active therapy. Patients on combination antiviral therapy are ineligible because of the potential for pharmacokinetic interactions with everolimus and or lenalidomide. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in this patient population.
  • Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
  • Symptomatic brain metastasis. Patients with treated brain metastasis must be completely weaned off of steroid therapy for at least 14 days prior to starting protocol therapy.
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.
  • Diagnosed venous thromboembolic disease within the preceding 6 months (patient on full dose or prophylactic anticoagulation are eligible).
  • Patients receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s) are ineligible. Lists of excluded medications and substances known or with the potential to interact with the cytochrome P450 (CYP450) enzyme(s) are provided.
  • History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 3 years.
  • Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
  • Patients with an active, bleeding diathesis.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Phase I Study of Everolimus (RAD001) in Combination With Lenalidomide in Patients With Advanced Solid Malignancies Enriched for Renal Cell Carcinoma

The purpose of this study is to study the combination of two anticancer drugs, everolimus (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard treatment or patients who are unable to tolerate the standard treatment for their cancer.

Read the detailed description

The purpose of this study is to study the combination of two anticancer drugs, everolimus (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard treatment or patients who are unable to tolerate the standard treatment for their cancer. The investigators seek to establish the safety of taking these two medications together and to determine the appropriate doses of the two drugs when given together as well as identify potential side effects when the drugs are administered together.

Another purpose of this study is to find out if the medication works for the patient's kind of cancer and side effects of the combination of RAD001 and lenalidomide by looking at the patient's response to the treatment. The investigators want to find out what effects, good or bad, the drugs have on the patient's cancer.

This study will also look at specific substances called biomarkers in the patient's blood and in the tumor tissue which are involved in the growth of tumor cells and determine if the levels of these biomarkers are related to the patient's response to treatment or development of side effects.

An expansion cohort is currently enrolling patients with adenoidcystic carcinoma, neuroendocrine and kidney cancer.

Keywords
kidney cancer, adenoidcystic cancer
Medical subject headings
Neuroendocrine Tumors, Kidney Neoplasms

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    Lenalidomide (10mg, 15mg, 20mg or 25mg) once daily by mouth, every day of each 28-day cycle.

  • EverolimusDrug

    Also called RAD001, Afinitor

    5mg or 10mg of everolimus administered once daily by mouth on a once daily continuous dosing schedule for 28 days.

Study groups in NCT01218555
Study groupRoleWhat they receive
Lenalidomide combination with everolimusExperimentalNon-randomized study of escalating doses of daily, orally administered lenalidomide in combination with standard doses of everolimus, an orally available mammalian target of rapamycin (mTOR) inhibitor.
Receives: Drug: Lenalidomide; Drug: Everolimus

What is being measured

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

  1. Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level

    A standard 3 + 3 design was employed to study escalating doses of daily, orally administered lenalidomide and everolimus. Dose escalation to the next cohort required 0 of 3 or ≤1 of 6 patients with dose-limiting toxicity (DLT). Five dose cohorts were planned starting at dose level one with lenalidomide 10 mg and everolimus 5mg in a 28-day cycle up to maximum doses of 25 and 10 mg, respectively.

    Measured: Within the first 28 days for DLT and throughout the duration of the study for safety.

Timeline

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

  1. First posted11 Oct 2010 (estimated)
  2. Study start9 Sep 2010
  3. Primary completion5 Nov 2020
  4. Study completion5 Nov 2020

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218555
Sponsor's protocol ID
IRB00031088
Other IDs
WCI1717-09
Status last verified
Nov 2021
First submitted
8 Oct 2010
Last updated
27 Jan 2022
Data monitoring committee
Yes

Publications

  • Harvey RD, Carthon BC, Lewis C, Hossain MS, Zhang C, Chen Z, Harris WB, Alese OB, Shaib W, Bilen MA, Lawson DH, Wu C, Steuer CE, El-Rayes BF, Khuri FR, Lonial S, Waller EK, Ramalingam SS, Owonikoko TK. Phase 1 safety and pharmacodynamic study of lenalidomide combined with everolimus in patients with advanced solid malignancies with efficacy signal in adenoid cystic carcinoma. Br J Cancer. 2020 Oct;123(8):1228-1234. doi: 10.1038/s41416-020-0988-2. Epub 2020 Jul 24.

    PubMed 32704173

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide and Everolimus in people with Solid Organ Malignancies and Adenoidcystic Carcinoma, run by Emory University at 2 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 21 inclusion and 18 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: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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.

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 27 Jan 2022). 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?

Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level (time frame: Within the first 28 days for DLT and throughout the duration of the study for safety.). 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 NCT01218555, 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 27 Jan 2022.

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