Advanced Solid TumorsPhase 1NCT00794781
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects With Advanced Solid Tumors
A Phase 1 study testing E6201 in people with Advanced Solid Tumors, run by Eisai Inc. at 12 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- E6201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 12 sitesUnited States
- Study dates
- 22 Jun 2008to 15 Oct 2015
- 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
- Subjects must meet all of the following criteria to be eligible to participate in this study:
- Willing and able to comply with the protocol and provide written informed consent.
- Age greater than or equal to 18 years.
- Histologically and/or cytologically confirmed metastatic melanoma which has progressed after treatment with approved therapies or for which there are no standard effective therapies available. CNS metastases from a primary melanoma are allowed.
- Subjects must have melanoma tumor status established by a BRAF-gene analysis report from a CLIA qualified laboratory.
- Subjects must have at least one tumor lesion accessible to biopsy in addition to one which is accurately and serially measurable according to RECIST 1.0 using either CT/MRI or photography (as appropriate), and which measures greater than 1.5 cm in the longest diameter for a non-lymph node and greater than 2.0 cm in the short axis diameter for a lymph node.
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- Female subjects of childbearing potential must agree to use medically acceptable methods of contraception, such as abstinence, double-barrier method (e.g., condom and spermicide; condom, diaphragm, and spermicide), intrauterine device (IUD), or have a vasectomised partner. Female subjects who use hormonal contraceptives must also use an additional approved method of contraception (as described previously). Contraceptive measures must start either prior to or at Screening and continue throughout the entire study period and for 2 months after the last dose drug is administered. Pregnant and/or lactating females are excluded.
- Male subjects must agree to use contraceptive methods such as abstinence, or double-barrier method (e.g., condom and spermicide; condom, diaphragm, and spermicide). Contraceptive measures must start either prior to or at Screening and continue throughout the entire study period and for 2 months after the last dose of study drug is administered.
- Adequate bone marrow function defined as:
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
- Hemoglobin greater than or equal to 9.0 g/dL; however, a hemoglobin value less than 9.0 g/dL is acceptable if it is corrected to greater than or equal to 9.0 g/dL by growth factor or transfusion before the start of treatment
- Platelet count greater than or equal to 100 x 10^9/L.
- Adequate renal function defined as:
- Serum creatinine less than 1.5 mg/dL or calculated creatinine clearance greater than 50 mL/minute per the Cockcroft-Gault formula 10 Adequate liver function defined as:
- Total Bilirubin within normal limits
- Alkaline phosphatase (AP), alanine transaminase (ALT), and aspartate transaminase (AST) less than or equal to 2.5 x upper limit of normal (ULN)
- AP, ALT, and AST less than or equal to 5 x ULN in the case of liver metastases and liver-specific AP less than or equal to 3 x ULN in the case of bone metastases 11 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
- 12. Life expectancy greater than 3 months.
Who cannot join
- Subjects who meet any of the following criteria are not eligible to participate in this study:
- Known human immunodeficiency virus (HIV), clinical evidence of active viral hepatitis B or C, or severe/uncontrolled infections or intercurrent illness that is unrelated to the tumor.
- Prior surgery, radiotherapy, chemotherapy, biologic therapy, or investigational agents within 4 weeks prior to the first infusion and prior immunotherapy, hormonal, or molecular-targeted therapy within 2 weeks prior to the first infusion. All acute toxicities related to prior treatments should have resolved.
- Active malignancy other than the present diagnosis within the past 24 months (except treated non-melanoma skin cancer or carcinoma in situ of the cervix).
- QT interval corrected for rate (QTc) greater than 450 msec on the electrocardiogram (ECG) obtained at Screening (Day -21 to 0) using the Fridericia method for QTc analysis.
- History or substance or alcohol abuse which, in the opinion of the investigator, would prohibit participation in the study.
- History of clinically significant cardiac impairment, congestive heart failure, New York Heart Association (NYHA) cardiac disease classification Class II, unstable angina, or myocardial infarction during the previous 6 months, or serious cardiac arrhythmia.
- Current significant co-morbid disease which, in the opinion of the investigator, would exclude the subject from the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Albany, New York
Study site
Austin, Texas
Study site
Dallas, Texas
Study site
Greenville, South Carolina
Study site
Las Vegas, Nevada
Study site
Lebanon, New Hampshire
Study site
Los Angeles, California
Study site
Norfolk, Virginia
Study site
San Antonio, Texas
Study site
Scottsdale, Arizona
Study site
Tyler, Texas
Study site
Vancouver, Washington
About this study
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201 in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- E6201
- Keywords
- Cancer, solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6201Drug
E6201 Part A (Dose Escalation): Intravenous (IV) infusion administered over 30 minutes once weekly for 3 weeks (Days 1, 8, and 15). The first 3 to 6 subjects of the first cohort will receive 20 mg/m^2/week for a cycle of 3 weeks followed by a 1-week rest period. Subsequent dose escalations may increase at increments of 100% until two Grade 2 toxicities or 1 dose-limiting toxicity (DLT) are observed in a dose group. Thereafter, doses will be increased in increments of 50% or less until the maximum tolerated dose (MTD) is determined. Part B (MTD Expansion): After the MTD is determined in Part A, 15 additional subjects will continue to receive cycles at the MTD.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E6201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose and dose-limiting toxicities as determined in Part A.
Measured: During Cycle 1: 28 days
Safety parameters (adverse events, laboratory data, vital signs, electrocardiogram data, Eastern Cooperative Oncology Group [ECOG] scores, and physical and neurological exams).
Measured: During Parts A and B: approximately 26 months
Secondary outcomes (3)
Pharmacokinetics
Measured: Obtained prior to infusion on Day 1 of Cycle 1 (Baseline), during the infusion at 15 and 30 minutes (just prior to end of infusion), then after the end of infusion at 5 and 30 minutes, and 1, 2, 4, 8, 24, and 48 hours on Days 1 and 15 of Cycle 1 only.
Pharmacodynamics
Measured: Prior to and post-infusion at timepoints between Days 1 and 15, and on Day 1 of Cycle 2
Preliminary efficacy: Tumor assessments of objective response rate based on review of computed tomography and magnetic resonance imaging scans using Modified Response Evaluation Criteria in Solid Tumors.
Measured: Performed at baseline and every other cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study start22 Jun 2008
- Primary completion1 Aug 2011
- Study completion15 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisai Medical Services, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794781
- Sponsor's protocol ID
- E6201-A001-102
- Status last verified
- Oct 2022
- First submitted
- 19 Nov 2008
- Last updated
- 14 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00794781
- Acronym / sponsor ID
- E6201-A001-102
- Conditions
- Advanced Solid Tumors
- Keywords
- Cancer, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2008 (actual)
- Primary completion
- 1 Aug 2011 (actual)
- Study completion
- 15 Oct 2015 (actual)
- First posted
- 20 Nov 2008 (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), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E6201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects must meet all of the following criteria to be eligible to participate in this study:
- Willing and able to comply with the protocol and provide written informed consent.
- Age greater than or equal to 18 years.
- Histologically and/or cytologically confirmed metastatic melanoma which has progressed after treatment with approved therapies or for which there are no standard effective therapies available. CNS metastases from a primary melanoma are allowed.
- Subjects must have melanoma tumor status established by a BRAF-gene analysis report from a CLIA qualified laboratory.
Key exclusion criteria (8 listed)
- Subjects who meet any of the following criteria are not eligible to participate in this study:
- Known human immunodeficiency virus (HIV), clinical evidence of active viral hepatitis B or C, or severe/uncontrolled infections or intercurrent illness that is unrelated to the tumor.
- Prior surgery, radiotherapy, chemotherapy, biologic therapy, or investigational agents within 4 weeks prior to the first infusion and prior immunotherapy, hormonal, or molecular-targeted therapy within 2 weeks prior to the first infusion. All acute toxicities related to prior treatments should have resolved.
- Active malignancy other than the present diagnosis within the past 24 months (except treated non-melanoma skin cancer or carcinoma in situ of the cervix).
- QT interval corrected for rate (QTc) greater than 450 msec on the electrocardiogram (ECG) obtained at Screening (Day -21 to 0) using the Fridericia method for QTc analysis.
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 |
|---|---|---|
| E6201E6201 Part A (Dose Escalation): Intravenous (IV) infusion administered over 30 minutes once weekly for 3 weeks (Days 1, 8, and 15). The first 3 to 6 subjects of the first cohort will receive 20 mg/m^2/week for a cycle of 3 weeks followed by a 1-week rest period. Subsequent dose escalations may increase at increments of 100% until two Grade 2 toxicities or 1 dose-limiting toxicity (DLT) are observed in a dose group. Thereafter, doses will be increased in increments of 50% or less until the maximum tolerated dose (MTD) is determined. Part B (MTD Expansion): After the MTD is determined in Part A, 15 additional subjects will continue to receive cycles at the MTD. | Drug | 1 |
Primary outcome
Maximum tolerated dose and dose-limiting toxicities as determined in Part A.
Time frame: During Cycle 1: 28 days
Safety parameters (adverse events, laboratory data, vital signs, electrocardiogram data, Eastern Cooperative Oncology Group [ECOG] scores, and physical and neurological exams).
Time frame: During Parts A and B: approximately 26 months
3 secondary outcomes
Pharmacokinetics
Time frame: Obtained prior to infusion on Day 1 of Cycle 1 (Baseline), during the infusion at 15 and 30 minutes (just prior to end of infusion), then after the end of infusion at 5 and 30 minutes, and 1, 2, 4, 8, 24, and 48 hours on Days 1 and 15 of Cycle 1 only.
Pharmacodynamics
Time frame: Prior to and post-infusion at timepoints between Days 1 and 15, and on Day 1 of Cycle 2
Preliminary efficacy: Tumor assessments of objective response rate based on review of computed tomography and magnetic resonance imaging scans using Modified Response Evaluation Criteria in Solid Tumors.
Time frame: Performed at baseline and every other cycle.
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 14 Oct 2022.
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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.
Eisai Medical Services study director
Eisai Inc.
12 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 E6201 in people with Advanced Solid Tumors, run by Eisai Inc. at 12 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 18 inclusion and 8 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Maximum tolerated dose and dose-limiting toxicities as determined in Part A. (time frame: During Cycle 1: 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?
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 14 Oct 2022.