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Cancer, Malignant TumorsPhase 1NCT00130169

A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies

A Phase 1 study testing E7974 in people with Cancer, Malignant Tumors, run by Eisai Inc. 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 determine the maximum tolerated dose (MTD) of E7974 administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies that have progressed following effective therapy or for which no effective therapy exists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Malignant Tumors
What is being tested?
E7974
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
Jan 2006to Aug 2009
Phase
Phase 1
Are there results?
None posted in the registry

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 who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for entry into the study:
  • Patients must have a pathologically diagnosed, histologically or cytologically confirmed solid malignancy that has progressed following effective therapy or for which no effective therapy exists (including surgery or radiation therapy).
  • Patients must be >= 18 years of age.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or 2.
  • Patients must have a life expectancy of >= 3 months.
  • Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL or creatinine clearance >= 40 mL/minute (min)
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  • Patients must have adequate bone marrow function as evidenced by absolute neutrophil count >= 1,200/µL, hemoglobin of >= 9 g/dL (may be transfused), and platelet count (not transfused) >= 100,000/µL.
  • Patients must have adequate liver function as evidenced by bilirubin <= 1.5 mg/dL and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 times the upper limits of normal (ULN), unless related to liver involvement by tumor, in which case <= 5.0 times ULN.
  • Patients must be willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study.
  • Patients must be willing and able to undergo blood draw and urine sampling for PK in Cycle 1.
  • Patients may have either measurable or non-measurable disease.
  • For Prostate Cancer patients only being enrolled at the MTD expansion phase:
  • Males with histologically proven adenocarcinoma of the prostate that has progressed (i.e. a minimum of three successive baseline values to document two consecutive rises in Prostate Specific Antigen (PSA) (with the last value 5 ng/mL) taken at least one week apart prior to study entry) despite castration or maintenance of castrate-level testosterone (defined as serum testosterone 50 ng/dL or 1.7 nmol/L), during non-hormonal chemotherapy.
  • Patients must have failed at least one previous chemotherapeutic regimen with tubulin binding agents such as docetaxel.
  • Exclusion Criteria:The presence of one or more of the following criteria will disqualify a patient from enrollment in the study:
  • Patients who have received chemotherapy within three weeks of E7974 treatment start (6 weeks for a nitrosourea).
  • Patients who have not recovered from any chemotherapy-related or other therapy-related toxicity to <= Grade 1 at study entry (excluding Grade 2 alopecia).
  • Patients who have received radiotherapy <= 3 weeks prior to study enrollment, whose marrow exposure has exceeded 25% and who have not recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia).
  • Patients who have had major surgery without full recovery or major surgery within three weeks of E7974 treatment start.
  • Patients with primary brain tumors or metastasis at study entry must have controlled them for >= 1 month by previous treatment, including radiation therapy and corticosteroids.
  • Women who are pregnant or breastfeeding.
  • Women of childbearing potential with either a positive serum pregnancy test at screening or no pregnancy test.
  • Women of childbearing potential unless (1) surgically sterile, (2) physiologically postmenopausal for >= 12 months, or (3) using adequate measures (including barrier methods) of contraception.
  • Fertile men or their partners who are not willing to use contraception.
  • Patients who have a history of positive testing for Human Immunodeficiency Virus (HIV) and/or have active hepatitis B or active hepatitis C at study entry.
  • Patients with severe, uncontrolled intercurrent illness or infection.
  • Patients with medically uncontrolled cardiovascular illness defined as unstable angina, >= symptomatic Grade II New York Heart Association (NYHA) Classification congestive heart failure (CHF), or myocardial infarction within six months prior to study entry.
  • Patients who have received organ allografts requiring immunosuppressive therapy.
  • Patients who have received investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy, or chemotherapy within the three-week period prior to E7974 treatment start; patients must have recovered from any previous major therapy-related toxicities (Grade 3 or 4) to <= Grade 1 at study entry (excluding Grade 2 alopecia).
  • Patients with a current history of peripheral neuropathy > CTC Grade 1 (e.g., diabetic or chemotherapy-induced neuropathy).
  • Patients with a history of uncontrolled seizures.
  • Patients with marked baseline prolongation of QT/QTc interval (QTc interval >470) using the Fridericia method as the main method of QTc analysis.
  • Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.
  • Patients with allergy or hypersensitivity to hemiasterlin based product or analogue.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • University Hospital Medical Center - SUNY at Stony Brook

    Stony Brook, New York, 11794

Other trials in United States

About this study

The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies that have progressed following effective therapy or for which no effective therapy exists.

Being tested
E7974
Keywords
Cancer, malignant tumors
Medical subject headings
Neoplasms

What participants receive

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

  • E7974Drug

    Maximum Tolerated Dose defined as 0.35 mg/m^2 administered on Days 1 and 15 only of a 28-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.

Study groups in NCT00130169
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: E7974

What is being measured

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

  1. Determine the maximum tolerated dose of E7974 in patients with solid malignancies.

    Measured: Duration of each cycle will be 28 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.

Secondary outcomes (1)

  1. Assess E7974 for safety, efficacy, pharmacokinetics and pharmacodynamics; evaluate the efficacy of E7974 in patients with metastatic, refractory prostate cancer.

    Measured: Duration of each cycle will be 28 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.

Timeline

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

  1. First posted15 Aug 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionAug 2009
  4. Study completionAug 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130169
Sponsor's protocol ID
E7974-A001-102
Status last verified
Jun 2015
First submitted
12 Aug 2005
Last updated
1 Jul 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7974 in people with Cancer, Malignant Tumors, run by Eisai Inc. 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 34 inclusion and 0 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 1 Jul 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Determine the maximum tolerated dose of E7974 in patients with solid malignancies. (time frame: Duration of each cycle will be 28 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.). 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 NCT00130169.

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 1 Jul 2015.

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