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Stage IV MelanomaPhase 1/2NCT01133977

E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma

A Phase 1/2 study testing Lenvatinib and Dacarbazine in people with Stage IV Melanoma, run by Eisai Inc. at 27 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

Primary: Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine. Phase II: To evaluate the safety and tolerability of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Melanoma
What is being tested?
Lenvatinib and Dacarbazine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
27 sitesin 5 countries
Study dates
Apr 2010to Nov 2014
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

  • Patients with histologically-confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer (AJCC)).
  • No prior cytokine, chemotherapy, or targeted therapy for Stage IV melanoma.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Life expectancy greater than or equal to 3 months.
  • At least 1 site of measurable disease by RECIST 1.1.
  • Adequate hematologic, renal, liver, and coagulation system function as defined by laboratory values performed within 21 days prior to initiation of dosing.
  • Blood pressure must be well-controlled (less than or equal to 140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy.

Who cannot join

  • Known central nervous system (CNS) lesions, except for asymptomatic, nonprogressive, treated brain metastases. Treatment for brain metastases must have been completed at least 4 weeks prior to Day 1 and may include whole brain radiotherapy (WBRT), radiosurgery [RS; Gamma Knife, linear accelerator (LINAC), or equivalent] or a combination as deemed appropriate by the treating physician. Dexamethasone must be discontinued at least 3 weeks prior to Day 1. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
  • Lactate dehydrogenase greater than or equal to 2.0 x upper limit of normal (ULN).
  • Subjects with proteinuria greater than 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with 24-hour urine protein greater than or equal to 1 g/24 hours will be ineligible.
  • Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures.
  • Other active malignancy.
  • History of or known carcinomatous meningitis.
Show all 13Show fewer
  • History of or known ocular melanoma.
  • Are currently receiving any other treatment for the tumor (including palliative radiotherapy) aside from control of symptoms.
  • Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to grade less than or equal to 1, except for alopecia.
  • Received radiotherapy within the 30 days prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to grade less than or equal to 1, except for alopecia.
  • Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment. Minor surgery such as Portacath placement or skin biopsy is permitted if greater than or equal to 7 days have passed.
  • History of bleeding diathesis or coagulopathy.
  • Current use of anti-coagulants such as Vitamin K antagonists, unfractionated heparin, or low molecular weight heparin.

Trial locations and contacts

27 sites in 5 countries.

27 sites in 5 countries

United Kingdom7 sites

  • Study site

    Dorset

  • Study site

    Glasgow

  • Study site

    Manchester

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Middlesex

  • Study site

    Oxford

  • Study site

    Southampton

Other trials in United Kingdom

United States5 sites

  • Study site

    Albany, New York

  • Study site

    Dallas, Texas

  • Study site

    Greenville, South Carolina

  • Study site

    Hagerstown, Maryland

  • Study site

    Norfolk, Virginia

Other trials in United States

Germany5 sites

  • Study site

    Berlin, 10249

  • Study site

    Berlin, 12351

  • Study site

    Berlin, 13585

  • Study site

    Heidelberg, 69120

  • Study site

    München, 81675

Other trials in Germany

Italy5 sites

  • Study site

    Bari, 70126

  • Study site

    Milan, 20133

  • Study site

    Milian, 20141

  • Study site

    Naples, 80131

  • Study site

    Siena, 53100

Other trials in Italy

Spain5 sites

  • Study site

    Barcelona

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28050

  • Study site

    Valenica, 46014

Other trials in Spain

About this study

Official title: An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma.

Primary:

  • Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine.
  • Phase II: To evaluate the safety and tolerability of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.

Secondary:

-Phase II: To make a preliminary assessment of the efficacy of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.

Read the detailed description

Safety was assessed by monitoring and recording all treatment emergent adverse events (AEs) and serious adverse events (SAEs); regular monitoring of clinical laboratory parameters; periodic measurement of vital signs and electrocardiograms (ECGs); dose limiting toxicities; performance of physical examinations; concomitant medications and procedures.

Being tested
Lenvatinib, Dacarbazine
Medical subject headings
Melanoma

What participants receive

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

  • LenvatinibDrug

    Also called E7080

    Lenvatinib tablets administered orally at doses of 16 mg, 20 mg, or 22 mg, once daily continuously over 3 weeks (21 days) during each 21-day cycle

  • LenvatinibDrug

    Also called E7080

    Lenvatinib 20 mg (MTD/recommended Phase 2 dose as determined in Phase 1b of the study) administered once daily continuously over 3 weeks (21 days) during each 21-day cycle

  • DacarbazineDrug

    Also called Dacarbazine (DTIC)-Dome

    Dacarbazine (1000 mg/m2) infusion over 60 minutes on Day 1 of each 21-day cycle.

Study groups in NCT01133977
Study groupRoleWhat they receive
Lenvatinib + Dacarbazine (Phase 1b)ExperimentalParticipants received 16 mg, 20 mg or 22 mg lenvatinib once daily in combination with dacarbazine
Receives: Drug: Lenvatinib; Drug: Dacarbazine
Lenvatinib + Dacarbazine (Phase 2)ExperimentalParticipants received lenvatinib per the maximum tolerated dose (MTD) as determined in the Phase Ib of the study in combination with dacarbazine
Receives: Drug: Lenvatinib; Drug: Dacarbazine
Dacarbazine (Phase 2)Active comparatorParticipants received dacarbazine
Receives: Drug: Dacarbazine

What is being measured

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

  1. Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)

    DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.

    Measured: From Day 1 through 21 days (one cycle)

  2. Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)

    Safety assessments consisted of monitoring and recording all AEs, including all Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0) grades, and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Details of AEs and SAEs are provided in the reported adverse event section.

    Measured: From signing of informed consent up to 30 days after the last dose, up to approximately 2 years

Secondary outcomes (1)

  1. Progression Free Survival (PFS) (for Phase 2)

    PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression of such participant's disease based on Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST v. 1.1) or (2) the date of such participant's death due to any cause. Progression was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions, based on Investigator assessment according to RECIST 1.1. If missing assessments, imputed dates were used in the analysis.

    Measured: From the date of randomization until the date of disease progression or death (whichever was earlier) or up to approximately 2 years

Timeline

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

  1. First posted31 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJun 2014
  4. Study completionNov 2014

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01133977
Sponsor's protocol ID
E7080-702
Status last verified
Aug 2016
First submitted
21 May 2010
Last updated
10 Oct 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenvatinib and Dacarbazine in people with Stage IV Melanoma, run by Eisai Inc. at 27 sites in 5 countries.

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 7 inclusion and 13 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 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United Kingdom, United States, Germany, Italy, Spain. 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 10 Oct 2016). 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?

Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b) (time frame: From Day 1 through 21 days (one cycle)). 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 NCT01133977.

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 10 Oct 2016.

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