Ovarian NeoplasmsPhase 2NCT00043446
Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
A Phase 2 study testing intravenous T900607-sodium in people with Ovarian Neoplasms, run by Tularik at 5 sites in United States.
Trial summary
The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- intravenous T900607-sodium
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2002to not given
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of ovarian cancer
- Subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel)
- At least 18 years of age
- Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
- Karnofsky performance status of at least 70%
- Estimated life expectancy of at least 12 weeks
Show all 18Show fewer
- Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
- Subject must be able to comply with study procedures and follow-up examinations.
- Signed written informed consent
- Lab Values (obtained ≤ 7 days prior to study enrollment):
- ANC at least 1.5x10e9/L,
- Platelet count at least 100x10e9/L,
- Hemoglobin at least 8.5 g/dL,
- Creatinine within 2 times upper limit of normal
- AST and ALT within 3 times upper limit of normal
- Bilirubin within 1.5 times upper limit of normal
- Albumin great than 2.5 g/dL
- INR < 1.5 for subjects without anticoagulants
Who cannot join
- Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
- NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms
- Patients who have received any investigational agent within 4 weeks of enrollment
- Patients who are pregnant or breast-feeding
- History of prior malignancy other than ovarian cancer within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- History of central nervous system metastases or carcinomatous meningitis
- Major surgery within 4 weeks of enrollment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Center
Buffalo, New York, 14263
Scripps Health Center
La Jolla, California, 92037
USC Women's and Children's Hospital
Los Angeles, California, 90033
University of California San Francisco
San Francisco, California, 94115
About this study
The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.
- Conditions
- Ovarian Neoplasms
- Being tested
- intravenous T900607-sodium
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous T900607-sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2002 (estimated)
- Study startJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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
- 35 participants
Sponsor and investigators
- Lead sponsor
- Tularik
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kerrie Boyd, Study chair, Tularik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043446
- Sponsor's protocol ID
- T-607-005
- Status last verified
- Apr 2004
- First submitted
- 8 Aug 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT00043446
- Acronym / sponsor ID
- T-607-005
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants
- Lead sponsor
- TularikIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- First posted
- 12 Aug 2002 (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 whether T900607-sodium is effective and safe in treating ovarian cancer.
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
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed diagnosis of ovarian cancer
- Subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel)
- At least 18 years of age
- Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
- Karnofsky performance status of at least 70%
Key exclusion criteria (7 listed)
- Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
- NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms
- Patients who have received any investigational agent within 4 weeks of enrollment
- Patients who are pregnant or breast-feeding
- History of prior malignancy other than ovarian cancer within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
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 |
|---|---|---|
| intravenous T900607-sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Kerrie Boyd study chair
Tularik
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravenous T900607-sodium in people with Ovarian Neoplasms, run by Tularik at 5 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 7 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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. 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?
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.
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 24 Jun 2005.