CancerPhase 1NCT00499499
A Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors
A Phase 1 study testing E7107 in people with Cancer, run by Eisai Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to investigate E7107 in patients with solid tumors. This is an open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single agent will be established by determining the occurrence of dose limiting toxicities during the first three weeks of therapy (Cycle 1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- E7107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Aug 2010
- 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 must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.
- Patients with histologically and/or cytologically confirmed solid tumors who have progressed after receiving approved therapies for their disease and for whom no effective therapies are available.
- Surgery and radiotherapy must have been completed at least four weeks prior to study entry, and prior chemotherapy and other anti-cancer therapy, excluding bisphosphonates at a steady dose level, must have been discontinued 2 to 3 weeks previously. All acute toxicities related to these treatments must have resolved.
- Aged ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Written informed consent prior to any study specific screening procedures, which will include mandatory consent to provide a blood sample specifically for pharmacogenomic analysis, with the understanding that the patient may withdraw consent at any time without prejudice. Tumor biopsy for pharmacogenomic (PG) analysis will be voluntary.
- Willing and able to comply with the protocol for the duration of the study.
- Anticipated life expectancy > three months.
Who cannot join
- Patients with the following characteristics will not be eligible for the study.
- Symptomatic or progressive brain tumors or brain or leptomeningeal (CNS) metastases requiring clinical intervention, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7107.
- Any of the following laboratory parameters:
- hemoglobin < 9 g/dL (5.6 mM)
- neutrophils < 1.5 x 10^9/L
- platelets < 100 x 10^9/L
Show all 22Show fewer
- serum bilirubin > 25 μM (1.5 mg/dL)
- liver function tests (defined as AST and ALT) with values > 3 x ULN (5 x ULN if liver metastases are present)
- serum creatinine > 1.5 x ULN or creatinine clearance < 40 mL/min.
- Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.
- Clinically significant cardiac impairment or unstable ischemic heart disease (greater than Class II according to New York Heart Association (NYHA) classification) including a myocardial infarction within six months of study start.
- Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants
- History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance.
- Women who are pregnant or breast-feeding. Women of childbearing potential with either a positive serum pregnancy test at screening, a positive urine pregnancy test at the beginning of any cycle, or no pregnancy test. Women of childbearing potential unless using two forms of contraception, one of which must be a barrier method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Fertile men and fertile women who are not willing to use contraception, or fertile men or fertile women with a partner who is not willing to use contraception
- Patients with a marked screening or baseline prolongation of QT/QTc interval using the Fridericia formula (ie, repeated demonstration of a QTc interval > 450 msec); a history of additional risk factors for Torsade de Pointe (e.g., heart failure, hypokalaemia, history of Long QT Syndrome).
- Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic radiation).
- Patients who have a history of previous Grade 2 or higher hypersensitivity to pladienolide B or derivatives and excipients of the formulation
- Patients with significant comorbid disease or condition, which in the Investigator's opinion would exclude the patient from the study
- Patients who have received an organ allograft ie, requiring immunosuppressive therapy
- Beginning two weeks prior to dosing, patients are not allowed to take drugs that are strong CYP inhibitors (including grapefruit juice and herbal supplements) or inducers (including herbal supplements), or are metabolized by cytochrome P (CYPs) and known to have a narrow therapeutic window.
- After MTD has been reached: Second malignancy within the past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma of the skin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Karmanos Cancer Center
Detroit, Michigan
M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors
The purpose of this study is to investigate E7107 in patients with solid tumors. This is an open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single agent will be established by determining the occurrence of dose limiting toxicities during the first three weeks of therapy (Cycle 1). Patients in this study will be treated at multiple dose levels, starting at 0.6 mg/m^2. Patients will receive E7107 as a 30-minute intravenous infusion on Days 1 and 8 every 21 Days.
- Conditions
- Cancer
- Being tested
- E7107
- 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.
E7107Drug
E7107 will be administered as an intravenous infusion over 30 minutes at a starting dose of 0.6 mg/m^2 to the first cohort of patients. The same dose will be given on Days 1 and 8 of a 21-day cycle. Dose escalation will not occur until the maximum tolerated dose is reached. The selection of subsequent dose levels will be performed according to an accelerated design.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E7107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor assessments should be performed at screening and then every 2 cycles. A best response according to RECIST (Response Evaluation Criteria in Solid Tumors) will be documented by the investigator for each patient.
Measured: Every 6 weeks
Secondary outcomes (1)
Clinical examination (either full or symptom-directed), adverse event reporting, laboratory screens, and electrocardiograms (ECGs) will be performed at every visit.
Measured: Every 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2009 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ewa Matczak, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499499
- Sponsor's protocol ID
- E7107-A001-101
- Status last verified
- Feb 2009
- First submitted
- 9 Jul 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
Publications
Hong DS, Kurzrock R, Naing A, Wheler JJ, Falchook GS, Schiffman JS, Faulkner N, Pilat MJ, O'Brien J, LoRusso P. A phase I, open-label, single-arm, dose-escalation study of E7107, a precursor messenger ribonucleic acid (pre-mRNA) splicesome inhibitor administered intravenously on days 1 and 8 every 21 days to patients with solid tumors. Invest New Drugs. 2014 Jun;32(3):436-44. doi: 10.1007/s10637-013-0046-5. Epub 2013 Nov 22.
PubMed 24258465
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00499499
- Acronym / sponsor ID
- E7107-A001-101
- Conditions
- Cancer
- Keywords
- Cancer, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 11 Jul 2007 (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 investigate E7107 in patients with solid tumors. This is an open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single agent will be established by determining the occurrence of dose limiting toxicities during the first three weeks of therapy (Cycle 1). Patients in this study will be treated at multiple dose levels, starting at 0.6 mg/m^2. Patients will receive E7107 as a 30-minute intravenous infusion on Days 1 and 8 every 21 Days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E7107 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.
- Patients with histologically and/or cytologically confirmed solid tumors who have progressed after receiving approved therapies for their disease and for whom no effective therapies are available.
- Surgery and radiotherapy must have been completed at least four weeks prior to study entry, and prior chemotherapy and other anti-cancer therapy, excluding bisphosphonates at a steady dose level, must have been discontinued 2 to 3 weeks previously. All acute toxicities related to these treatments must have resolved.
- Aged ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (22 listed)
- Patients with the following characteristics will not be eligible for the study.
- Symptomatic or progressive brain tumors or brain or leptomeningeal (CNS) metastases requiring clinical intervention, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7107.
- Any of the following laboratory parameters:
- Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.
- Clinically significant cardiac impairment or unstable ischemic heart disease (greater than Class II according to New York Heart Association (NYHA) classification) including a myocardial infarction within six months of study 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 |
|---|---|---|
| E7107E7107 will be administered as an intravenous infusion over 30 minutes at a starting dose of 0.6 mg/m^2 to the first cohort of patients. The same dose will be given on Days 1 and 8 of a 21-day cycle. Dose escalation will not occur until the maximum tolerated dose is reached. The selection of subsequent dose levels will be performed according to an accelerated design. | Drug | 1 |
Primary outcome
Tumor assessments should be performed at screening and then every 2 cycles. A best response according to RECIST (Response Evaluation Criteria in Solid Tumors) will be documented by the investigator for each patient.
Time frame: Every 6 weeks
1 secondary outcome
Clinical examination (either full or symptom-directed), adverse event reporting, laboratory screens, and electrocardiograms (ECGs) will be performed at every visit.
Time frame: Every 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Derived from this study: PubMed 24258465Hong DS, Kurzrock R, Naing A, Wheler JJ, Falchook GS, Schiffman JS, Faulkner N, Pilat MJ, O'Brien J, LoRusso P. A phase I, open-label, single-arm, dose-escalation study of E7107, a precursor messenger ribonucleic acid (pre-mRNA) splicesome inhibitor administered intravenously on days 1 and 8 every 21 days to patients with solid tumors. Invest New Drugs. 2014 Jun;32(3):436-44. doi: 10.1007/s10637-013-0046-5. Epub 2013 Nov 22.
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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.
Ewa Matczak 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 E7107 in people with 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 8 inclusion and 22 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: paused, as of the sponsor's last update on 4 Feb 2009. 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?
Results are not available in the source record.
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?
Tumor assessments should be performed at screening and then every 2 cycles. A best response according to RECIST (Response Evaluation Criteria in Solid Tumors) will be documented by the investigator for each patient. (time frame: Every 6 weeks). 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 NCT00499499, which also lists 1 linked publication.
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 4 Feb 2009.