Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00047034
E7389 in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing eribulin mesylate, pharmacological study and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- eribulin mesylate, pharmacological study and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Oct 2007
- 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
- Advanced, histologically-confirmed solid tumors refractory to standard therapy or for which no standard therapy exists
- Karnofsky performance status of at least 60% and estimated survival of at least two months
- Serum creatinine =< 1.5 mg/dl or creatinine clearance >= 60 ml/min
- ANC >= 1,500/ul
- Platelets >= 100,000/ul
- Bilirubin =< 1.5 mg/dl
Show all 18Show fewer
- SGOT and SGPT =< 2.5 times the upper limits of normal
- Prior to entry on study, a patient must be at least four weeks from prior chemotherapy (six weeks from nitrosoureas, 8 weeks from UCN-01) and have recovered from all side effects of prior therapy; there is no limit on the number of prior chemotherapy regimens
- Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
- Patients with brain metastases are INELIGIBLE for this study
- Due to concerns regarding possible drug interactions, patients with HIV taking anti-retroviral medications are INELIGIBLE
- Pregnant patients and patients who are breast feeding are INELIGIBLE; all patients of child-bearing potential, both male and female, must be advised to practice adequate contraception; premenopausal women must have a negative pregnancy test prior to entry on this study
- Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it inappropriate to treat the patient on this protocol are INELIGIBLE
- Patients currently being treated for a severe infection or who are recovering from major surgery are INELIGIBLE until recovery is deemed complete by the investigators
- All patients must have evaluable disease; the presence of measurable disease is NOT required for this phase I study; if unidimensionally measurable disease is present, baseline measurements of up to 3 indicator lesions should be made no earlier than four weeks prior to the first cycle of chemotherapy; pleural effusions, ascites and bone metastases are not considered measurable
- CBC, differential count, platelet count, and blood chemistries should be done no earlier than 72 hours prior to each cycle of chemotherapy
- Except for 4 weeks for tumor measurements and 72 hours for specified blood work, pretreatment tests should be done no earlier than two weeks prior to the first cycle of chemotherapy
- Once the MTD has been established, an additional10 patients will be accrued to obtain pre- and post-treatment biopsy material in order to validate the molecular targets of E7389 in man; therefore, to maximize likelihood of obtaining tissue from patients treated in the expanded MTD cohort, only patients with tumors appropriate for repeated biopsy are eligible during this stage of the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial of E7389 (Halichondrin B Analog) (NSC# 707389) in Patients With Advanced Solid Tumors
Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of E7389 administered as an IV bolus over 1-2 minutes weekly for 3 weeks.
II. To describe the toxicities of E7389. III. To evaluate the pharmacokinetics of E7389. IV. To determine the in vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry in pre- and post-treatment tumor biopsies.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
- Being tested
- eribulin mesylate, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eribulin mesylateDrug
Also called B1939, E7389, ER-086526, halichrondrin B analog
Given IV
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (eribulin mesylate) | Experimental | Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: eribulin mesylate; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of eribulin mesylate defined as the highest dose tested in which no more than 1 of first 6 patients evaluated for toxicity experience dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0
Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by cycle.
Measured: 28 days
Secondary outcomes (2)
Pharmacokinetics of eribulin mesylate
The pharmacokinetic data will be analyzed using compartmental and non-compartmental models for each patient.
Measured: At baseline and at the first and third dose of treatment
In vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry
Measured: At pre- and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2002
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert Morgan, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047034
- Sponsor's protocol ID
- NCI-2012-03076
- Other IDs
- PHI-39, U01CA062505, CDR0000257235
- Status last verified
- Jan 2013
- First submitted
- 3 Oct 2002
- Last updated
- 7 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of E7389 (Halichondrin B Analog) (NSC# 707389) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00047034
- Acronym / sponsor ID
- NCI-2012-03076
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2002
- Primary completion
- Oct 2007 (actual)
- First posted
- 27 Jan 2003 (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.
Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of E7389 administered as an IV bolus over 1-2 minutes weekly for 3 weeks.
II. To describe the toxicities of E7389. III. To evaluate the pharmacokinetics of E7389. IV. To determine the in vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry in pre- and post-treatment tumor biopsies.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (eribulin mesylate) | Experimental | Drug: eribulin mesylate, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Advanced, histologically-confirmed solid tumors refractory to standard therapy or for which no standard therapy exists
- Karnofsky performance status of at least 60% and estimated survival of at least two months
- Serum creatinine =< 1.5 mg/dl or creatinine clearance >= 60 ml/min
- ANC >= 1,500/ul
- Platelets >= 100,000/ul
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| eribulin mesylateAlso: B1939, E7389, ER-086526, halichrondrin B analogGiven IV | Drug | Treatment (eribulin mesylate) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (eribulin mesylate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (eribulin mesylate) |
Primary outcome
MTD of eribulin mesylate defined as the highest dose tested in which no more than 1 of first 6 patients evaluated for toxicity experience dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0
Time frame: 28 days
Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by cycle.
2 secondary outcomes
Pharmacokinetics of eribulin mesylate
Time frame: At baseline and at the first and third dose of treatment
In vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry
Time frame: At pre- and post-treatment
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 7 Jan 2013.
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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.
Robert Morgan principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eribulin mesylate, pharmacological study and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site 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 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 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
MTD of eribulin mesylate defined as the highest dose tested in which no more than 1 of first 6 patients evaluated for toxicity experience dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0 (time frame: 28 days). 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 7 Jan 2013.