Solid Tumor Malignancies, CancerPhase 1NCT00121732
An Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
A Phase 1 study testing E7974 in people with Solid Tumor Malignancies, Cancer, run by Eisai Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies, Cancer
- What is being tested?
- E7974
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Oct 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 tumor 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 or 1.
- 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 >= 1,500/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.
Who cannot join
- 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.
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- Women who are pregnant or breastfeeding.
- Women of childbearing potential with either a positive 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 positive history 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.
- Patients with a current history of peripheral neuropathy > CTC Grade 2 (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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Indianapolis, Indiana, 46202
CTRC
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, Two-Arm, Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.
Read the detailed description
This is a two-arm, open-label, non-randomized, dose-escalation study to determine the MTD of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists. Response and progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Conditions
- Solid Tumor Malignancies, Cancer
- Being tested
- E7974
- 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 = 0.15 mg/m^2 administered on Days 1, 8, 15 of 28-day cycle.
E7974Drug
Maximum tolerated dose = 0.37 mg/m^2 administered on Days 1 and 8 of 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: E7974 |
| B | Experimental | Not described Receives: Drug: E7974 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of E7974 in patients with solid malignancies.
Measured: Duration of each cycle will be 28 or 21 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 (PK), and pharmacodynamics (PD); 2) Evaluate the correlation of AUC with clinical toxicity and efficacy in both arms.
Measured: Duration of each cycle will be 28 or 21 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.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor Malignancies, CancerStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jenny Zhang, M.D., Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121732
- Sponsor's protocol ID
- E7974-A001-101
- Status last verified
- Jun 2015
- First submitted
- 15 Jul 2005
- Last updated
- 1 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Arm, Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
- ClinicalTrials.gov ID
- NCT00121732
- Acronym / sponsor ID
- E7974-A001-101
- Conditions
- Solid Tumor Malignancies, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.
Detailed description
This is a two-arm, open-label, non-randomized, dose-escalation study to determine the MTD of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists. Response and progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: E7974 |
| B | Experimental | Drug: E7974 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 tumor 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 or 1.
- Patients must have a life expectancy of >= 3 months.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E7974Maximum tolerated dose = 0.15 mg/m^2 administered on Days 1, 8, 15 of 28-day cycle. | Drug | A |
| E7974Maximum tolerated dose = 0.37 mg/m^2 administered on Days 1 and 8 of 21-day cycle. | Drug | B |
Primary outcome
Determine the maximum tolerated dose of E7974 in patients with solid malignancies.
Time frame: Duration of each cycle will be 28 or 21 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.
1 secondary outcome
1) Assess E7974 for safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD); 2) Evaluate the correlation of AUC with clinical toxicity and efficacy in both arms.
Time frame: Duration of each cycle will be 28 or 21 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Zhang, M.D. study director
Eisai Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E7974 in people with Solid Tumor Malignancies, Cancer, 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 11 inclusion and 20 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 or 21 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?
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.