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Carcinoma, Renal CellPhase 1NCT02454478

Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)

A Phase 1 study testing Lenvatinib and Everolimus in people with Carcinoma, Renal Cell, run by Eisai Co., Ltd. at 3 sites in Japan.

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

Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with Everolimus in participants with unresectable advanced or metastatic RCC. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Lenvatinib and Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesJapan
Study dates
1 Jul 2015to 29 May 2017
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary agreement to provide written informed consent of this study.
  • Willing and able to comply with all aspects of the protocol after being fully informed of the content.
  • Males or females aged greater than or equal to 20 years at the time of informed consent.
  • Histological or cytological confirmation of RCC.
  • Participants must have confirmed diagnosis of unresectable advanced and/or metastatic RCC.
  • Disease progression following vascular endothelial growth factor (VEGF) targeted therapy.
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  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1.
  • Adequately controlled blood pressure with or without the use of antihypertensive agents.
  • Participants with adequate function of major organs.
  • Adequate blood coagulation function, defined as international normalized ratio (INR) less than or equal to 1.5.
  • Survival expectation of 3 months or longer after study enrollment.
  • Participants with adequate washout period from the end of prior treatment to the start of study drug administration.
  • Females of childbearing potential must not have had unprotected sexual intercourse within 28 days before participant registration and must agree to use a highly effective method of contraception throughout the entire study period and for 30 days after final administration of investigational drug. If currently abstinent, the participant must agree to use a double-barrier method as described above if she becomes sexually active during this study period or for 30 days after investigational drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before administration and must continue to use the same contraceptive during this study and for 30 days after investigational drug discontinuation.
  • Male participants and their female partners must meet the criteria above.

Who cannot join

  • Participants with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
  • Prior exposure to lenvatinib.
  • Participants who have not recovered from toxicities to less than or equal to Grade 1 as a result of prior anticancer therapy, except alopecia.
  • Major surgery within 3 weeks prior to the first dose of lenvatinib.
  • Participants with a urine protein greater than or equal to 1 gram per 24 hours (g/24 hours).
  • Uncontrollable diabetes as defined by fasting glucose greater than 1.5* upper limit of normal (ULN).
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  • Fasting total cholesterol greater than 7.75 millimole per liter (mmol/L) (greater than 300 milligram per decilitre [mg/dL]).
  • Fasting triglycerides greater than 2.5 * ULN.
  • Any condition that might affect the absorption of lenvatinib and/or everolimus.
  • Significant cardiovascular impairment.
  • Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring.
  • Active hemoptysis.
  • Active infections that require systemic treatment.
  • Human immunodeficiency virus (HIV) positive.
  • Hepatitis B virus (HBV).
  • A history of interstitial pneumonia with clinical manifestation or as confirmed by means of diagnostic imaging.
  • Medical need for the continued use of potent or moderate inhibitors of cytochrome P450 3A (CYP3A) or P-gp, or potent or moderate inducer of CYP3A.
  • Known intolerance to lenvatinib (or any of the excipients) or known hypersensitivity to everolimus (or any of the excipients) or rapmycins (sirolimus, temsirolimus and so on).
  • Alcohol or drug dependency or abuse, inability to comply with every aspects of the study protocol, or any physical or mental conditions that in the opinion of the investigators would preclude the participant's participation in the study.
  • Females who are pregnant or breastfeeding (not eligible even she discontinues breastfeeding).
  • Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Eisai Trial Site #1

    Chiba

  • Eisai Trial Site #1

    Tokyo

  • Eisai Trial Site #2

    Tokyo

Other trials in Japan

About this study

Official title: Phase 1 Study of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic RCC

Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with Everolimus in participants with unresectable advanced or metastatic RCC.

Being tested
Lenvatinib, Everolimus
Keywords
lenvatinib, Everolimus, Carcinoma, Unresectable advanced renal cell carcinoma, Metastatic renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell, Carcinoma

What participants receive

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

Study groups in NCT02454478
Study groupRoleWhat they receive
Lenvatinib plus EverolimusExperimentalNot described
Receives: Drug: Lenvatinib; Drug: Everolimus

What is being measured

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

  1. Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)

    DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).

    Measured: From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)

Secondary outcomes (9)

  1. Cmax: Maximum Observed Plasma Concentration for Levatinib and Everolimus

    Measured: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)

  2. Css,Max: Maximum Observed Plasma Concentration at Steady State for Levatinib and Everolimus

    Measured: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)

  3. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Levatinib and Everolimus

    Measured: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)

  4. Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for Levatinib and Everolimus

    Measured: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)

  5. AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus

    Measured: Cycle 1 Day 1 and Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)

  6. Number of Participants With Best Overall Response (BOR)

    BOR included complete response (CR), partial response (PR), stable disease (SD), and PD (progressive disease). BOR was assessed using Response Evaluation Criteria in Solid Tumor (RECIST) 1.1

    Measured: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)

  7. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who achieved BOR of CR or PR. ORR was assessed using RECIST 1.1.

    Measured: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)

  8. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants who achieved BOR of CR, PR, or SD. DCR was assessed based on RECIST 1.1.

    Measured: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)

  9. Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions

    Measured: Baseline up to first tumor assessment at which diameter of target lesions were available (up to approximately 23 months)

Timeline

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

  1. First posted27 May 2015 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion29 May 2017
  4. Study completion29 May 2017

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02454478
Sponsor's protocol ID
E7080-J081-112
Status last verified
Sep 2018
First submitted
22 May 2015
Last updated
19 Mar 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenvatinib and Everolimus in people with Carcinoma, Renal Cell, run by Eisai Co., Ltd. at 3 sites in Japan.

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 14 inclusion and 21 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 19 Mar 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 Japan. 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 8 Feb 2019). 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 Who Experienced Any Dose Limiting Toxicity (DLT) (time frame: From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)). 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 NCT02454478.

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 19 Mar 2019.

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