Advanced Solid TumorsPhase 1NCT00116896
Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors
A Phase 1 study testing OSI-7904L and Cisplatin in people with Advanced Solid Tumors, run by OSI Pharmaceuticals at 2 sites in United States.
Trial summary
This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- OSI-7904L and Cisplatin
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2003to Dec 2004
- 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
- 18 years of age or older
- Advanced and/or metastatic solid tumor for which no effective therapy is available
- ECOG performance status 0-2
- Adequate bone marrow, hepatic and renal function
Who cannot join
- Patients with active or uncontrolled infections
- Neurotoxicity >= Grade 2
- Symptomatic brain metastases which are not stable
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt Universtiy Medical Center
Nashville, Tennessee, 37232-6307
Institute for Drug DevelopmentCancer Therapy & Research Center
San Antonio, Texas, 78229
About this study
Official title: Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors
This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- OSI-7904L, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-7904LDrug
CisplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startJun 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116896
- Sponsor's protocol ID
- OSI-904-102
- Status last verified
- Nov 2003
- First submitted
- 30 Jun 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00116896
- Acronym / sponsor ID
- OSI-904-102
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Dec 2004
- First posted
- 1 Jul 2005 (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.
This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.
Study design
- Primary purpose
- Treatment
- 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 (4 listed)
- 18 years of age or older
- Advanced and/or metastatic solid tumor for which no effective therapy is available
- ECOG performance status 0-2
- Adequate bone marrow, hepatic and renal function
Key exclusion criteria (3 listed)
- Patients with active or uncontrolled infections
- Neurotoxicity >= Grade 2
- Symptomatic brain metastases which are not stable
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 |
|---|---|---|
| OSI-7904L | Drug | – |
| Cisplatin | 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 21 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 OSI-7904L and Cisplatin in people with Advanced Solid Tumors, run by OSI Pharmaceuticals 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 4 inclusion and 3 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 21 Jan 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?
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 21 Jan 2009.