CancerPhase 1NCT00006199
Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)
A Phase 1 study testing R115777 (farnesyl transferase inhibitor) and Topotecan in people with Cancer, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
The purpose of this clinical trial is to establish the safest doses for the combination of a farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid tumors, previously treated or beyond standard therapy of clinical benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- R115777 (farnesyl transferase inhibitor) and Topotecan
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 with advanced solid tumors with previous treatment or beyond standard therapy of significant clinical benefit
- Therapy with no more than 3 prior chemotherapy regimens
- Radiotherapy to less than 25% of bone marrow volume (no pelvic radiation)
- Adequate organ function
- Recovery from the effects of prior chemotherapy and radiation therapy, with at least a 4 week interval. All prior toxicities should have resolved to baseline prior to entry into the study.
- Good performance status
Show all 12Show fewer
- Anticipate life expectancy of at least 6 months
- Not pregnant or lactating.
- Sexually active men and women of childbearing age must use adequate contraception.
- Be able to give signed, written informed consent.
- No gastrointestinal condition that could affect the absorption of the drug
- No active infection requiring systemic medical therapy one week prior to chemotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Anita Tierney contact
United States1 site, 1 recruiting
- Recruiting
NYU Cancer Institute
New York, New York, 10016
Anita Tierney, 212-263-2173
About this study
The purpose of this clinical trial is to establish the safest doses for the combination of a farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated dose, dose limiting toxicity and the activity of this combination will be assessed.
This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777 is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene, while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by the ras oncogene. Animal studies suggest that the combination may be synergistic. Another advantage is that R115777 can be taken by mouth.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R115777 (farnesyl transferase inhibitor)Drug
TopotecanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006199
- Sponsor's protocol ID
- NCRR-M01RR00096-1001
- Other IDs
- M01RR000096
- Status last verified
- Jan 2004
- First submitted
- 9 Sep 2000
- 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 the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)
- ClinicalTrials.gov ID
- NCT00006199
- Acronym / sponsor ID
- NCRR-M01RR00096-1001
- Conditions
- Cancer
- Keywords
- solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 11 Sep 2000 (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 clinical trial is to establish the safest doses for the combination of a farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated dose, dose limiting toxicity and the activity of this combination will be assessed.
This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777 is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene, while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by the ras oncogene. Animal studies suggest that the combination may be synergistic. Another advantage is that R115777 can be taken by mouth.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with advanced solid tumors with previous treatment or beyond standard therapy of significant clinical benefit
- Therapy with no more than 3 prior chemotherapy regimens
- Radiotherapy to less than 25% of bone marrow volume (no pelvic radiation)
- Adequate organ function
- Recovery from the effects of prior chemotherapy and radiation therapy, with at least a 4 week interval. All prior toxicities should have resolved to baseline prior to entry into the study.
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 |
|---|---|---|
| R115777 (farnesyl transferase inhibitor) | Drug | – |
| Topotecan | 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.
Anita Tierney contact
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 R115777 (farnesyl transferase inhibitor) and Topotecan in people with Cancer, run by National Center for Research Resources (NCRR) 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 12 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: 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita Tierney (1-212-263-2173), or a site near the patient. 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.