Completed

Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma

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What is being tested

E7820

Drug
Who is being recruted

Neoplasms

+ Lymphoma, Malignant
Over 18 Years
+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2004

See protocol details

Summary

Principal SponsorEisai Inc.
Last updated: December 23, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

This is a first-in-man, open-label, non-randomized, multiple dose, multiple cycle, dose escalation study to determine the MTD, safety, PK, and pharmacodynamics of E7820 in patients with a malignant solid tumor or lymphoma.

Official TitlePhase I and Pharmacokinetic Study of E7820 After Oral Administration to Patients With Malignancy 
Principal SponsorEisai Inc.
Last updated: December 23, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
37 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasms
Lymphoma, Malignant
Criteria
8 inclusion criteria required to participate
Patients must have a histologically or cytologically confirmed malignant solid tumor or lymphoma. Malignancy must be advanced and require systemic therapy. Malignancy must be one for which no standard therapy is available or the patient must not be a candidate for standard therapy
Patients must have a Karnofsky Performance Status of >= 70%
Patients must have a life expectancy of >= 3 months
Patients must be aged >= 18 years

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17 exclusion criteria prevent from participating
Patients who have a history of previous hypersensitivity to sulfonamide derivatives, Patients who have received chemotherapy within 4 weeks (6 weeks if nitrosoureas were received) of commencing study treatment
Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic radiation) within 4 weeks of E7820 treatment
Patients who have not recovered from any clinically significant chemotherapy or radiotherapy related toxicity at study entry
Patients who have received investigational drugs or other antineoplastic therapy within 28 days of E7820 treatment

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Unknown FacilitySan Antonio, United StatesSee the location
CompletedOne Study Center