Kidney NeoplasmsPhase 2NCT00059735
A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma
A Phase 2 study testing E7070 in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by Eisai Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms, Carcinoma, Renal Cell, Adenocarcinoma, Renal Cell
- What is being tested?
- E7070
- How many people
- 30 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2002to Dec 2003
- Phase
- Phase 2
- 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
- Age >=18 years old.
- Have histologically/cytologically confirmed clear cell RCC.
- Previously untreated or one prior treatment with immunotherapy (one prior treatment may be represented by single agent interferon, single agent interleukin-2 or a combination of interferon with interleukin-2 with or without accompanying hematological growth factors).
- Documented evidence of progressive disease in the previous 3 months. In the absence of radiographic studies, patients may be entered on the study if they have clinical evidence of progressive disease.
- Have at least one unidimensional measurable lesion of RCC according to the RECIST guidelines. The following will not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions.
- Be ambulatory and have a Karnofsky performance status >=70%.
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- Have a life expectancy of at least 3 months.
- Give written informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
- Be willing and able to comply with the study protocol for the duration of the study.
Who cannot join
- Woman 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 or (2) using adequate contraceptive measures (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Fertile male subjects not willing to use contraception and whose female partners are not under adequate contraceptive protection.
- Known CNS metastases (if clinical suspicion of CNS metastases exists appropriate imaging must be performed prior to study entry).
- Prior treatment with chemotherapy (there is no restriction on prior epidermal growth factor directed therapy).
- Severe and uncontrolled cardiac or cardiovascular abnormalities.
- Severe uncontrolled intercurrent infections.
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- Subjects with organ allografts.
- Any of the following abnormal screening hematological values: Hemoglobin (Hb) <9g /dL (6 mmol/L), Neutrophils <1.5 x 10^9/L, Platelets <100 x 10^9/L.
- Blood transfusions or growth factors to aid hematological recovery within 2 weeks prior to starting study treatment.
- Any of the following abnormal screening liver function tests: serum bilirubin >= 1.5 x upper normal limit (ULN), alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) >= 2.5 x ULN (unless related to liver metastases in which case >= 5 x ULN).
- The following abnormal screening renal function tests: either a serum creatinine > 1.5 x ULN or a creatinine clearance (estimated from serum creatinine) < 40 mL/minute.
- Prior radiotherapy (except palliative).
- Participation in any investigational drug study or immunotherapy within 4 weeks preceding treatment start.
- History of hypersensitivity to sulphonamides.
- Any concurrent or previous malignancy of a different tumor type within 5 years of starting E7070 treatment except for adequately treated non-melanoma skin cancer or cervical intra-epithelial neoplasia.
- Significant disease, which in the Investigator's opinion would exclude the patient from the study.
- Surgically resectable metastatic disease.
- Legal incapacity.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Study site
New York, New York, 10021
Study site
New York, New York, 10032
Study site
Sacramento, California, 95817
Study site
The Bronx, New York, 10466
About this study
Official title: A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)
The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.
Read the detailed description
Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.
- Being tested
- E7070
- Keywords
- kidney cancer, kidney neoplasms, renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7070Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startMay 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Murray Yule, MRCP, PhD, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059735
- Sponsor's protocol ID
- E7070-A001-206
- Status last verified
- Feb 2008
- First submitted
- 5 May 2003
- Last updated
- 5 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)
- ClinicalTrials.gov ID
- NCT00059735
- Acronym / sponsor ID
- E7070-A001-206
- Keywords
- kidney cancer, kidney neoplasms, renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- May 2002
- Study completion
- Dec 2003 (actual)
- First posted
- 7 May 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.
The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.
Detailed description
Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >=18 years old.
- Have histologically/cytologically confirmed clear cell RCC.
- Previously untreated or one prior treatment with immunotherapy (one prior treatment may be represented by single agent interferon, single agent interleukin-2 or a combination of interferon with interleukin-2 with or without accompanying hematological growth factors).
- Documented evidence of progressive disease in the previous 3 months. In the absence of radiographic studies, patients may be entered on the study if they have clinical evidence of progressive disease.
- Have at least one unidimensional measurable lesion of RCC according to the RECIST guidelines. The following will not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions.
Key exclusion criteria (18 listed)
- Woman 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 or (2) using adequate contraceptive measures (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Fertile male subjects not willing to use contraception and whose female partners are not under adequate contraceptive protection.
- Known CNS metastases (if clinical suspicion of CNS metastases exists appropriate imaging must be performed prior to study entry).
- Prior treatment with chemotherapy (there is no restriction on prior epidermal growth factor directed therapy).
- Severe and uncontrolled cardiac or cardiovascular abnormalities.
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 |
|---|---|---|
| E7070 | Drug | – |
Primary outcome
Not reported in the source record.
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 5 Mar 2008.
- Related InfoLink provided by the sponsor.
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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.
Murray Yule, MRCP, PhD study director
Eisai Limited
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E7070 in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by Eisai Inc. at 5 sites in 2 countries.
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 9 inclusion and 18 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 5 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 5 Mar 2008.