Solid Tumor CancerPhase 1NCT00119171
Ispinesib In Combination With Capecitabine In Patients With Solid Tumors
A Phase 1 study testing Ispinesib and Capecitabine in people with Solid Tumor Cancer, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer
- What is being tested?
- Ispinesib and Capecitabine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to 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
- Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
- Bone marrow function: - ANC greater than 1500/mm3.
- Platelet count greater than or equal to 100,000/mm3.
- Hemoglobin greater than 9 g/dL.
- Renal function: - Calculated creatinine clearance greater than or equal to 50 mL.min.
- Total bilirubin greater than 1.5 mg/dL.
- AST/ALT less than 2.5 X upper limit of normal.
Who cannot join
- Females who are pregnant or nursing.
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2.
- Known deficiency in dihydropyrimidine dehydrogenase (DSD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors
The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
- Conditions
- Solid Tumor Cancer
- Being tested
- Ispinesib, Capecitabine
- Keywords
- Safety, tolerability, dose limiting toxicity, solid tumors, capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IspinesibDrug
CapecitabineDrug
Also called Ispinesib
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels for SB-715992 and Capecitabine
Measured: will be checked at Day 1 for Cycle 1.
Secondary outcomes (3)
- Medical history
Measured: at screening
- ECOG Performance Status, Physical Exam, vitals, & labs
Measured: done at screening, Week 1 (each cycle), & follow-up (f/u)
- Continuous Adverse Event monitoring
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119171
- Sponsor's protocol ID
- KSP10004
- Status last verified
- Oct 2008
- First submitted
- 5 Jul 2005
- Last updated
- 16 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00119171
- Acronym / sponsor ID
- KSP10004
- Conditions
- Solid Tumor Cancer
- Keywords
- Safety, tolerability, dose limiting toxicity, solid tumors, capecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- First posted
- 13 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.
The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
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 (8 listed)
- Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
- Bone marrow function: - ANC greater than 1500/mm3.
- Platelet count greater than or equal to 100,000/mm3.
- Hemoglobin greater than 9 g/dL.
Key exclusion criteria (4 listed)
- Females who are pregnant or nursing.
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2.
- Known deficiency in dihydropyrimidine dehydrogenase (DSD).
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 |
|---|---|---|
| Ispinesib | Drug | – |
| CapecitabineAlso: Ispinesib | Drug | – |
Primary outcome
Plasma levels for SB-715992 and Capecitabine
Time frame: will be checked at Day 1 for Cycle 1.
3 secondary outcomes
- Medical history
Time frame: at screening
- ECOG Performance Status, Physical Exam, vitals, & labs
Time frame: done at screening, Week 1 (each cycle), & follow-up (f/u)
- Continuous Adverse Event monitoring
Time frame: throughout the study
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 16 Oct 2008.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
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 Ispinesib and Capecitabine in people with Solid Tumor Cancer, run by GlaxoSmithKline 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 8 inclusion and 4 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 16 Oct 2008. 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?
Plasma levels for SB-715992 and Capecitabine (time frame: will be checked at Day 1 for Cycle 1.). 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 16 Oct 2008.