Solid TumorsPhase 1NCT00420485
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing gimatecan in people with Solid Tumors, run by Novartis Pharmaceuticals at 12 sites in 7 countries.
Trial summary
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- gimatecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Mar 2006to Nov 2010
- 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
- Advanced or metastatic cancer
- 18 years and above
Who cannot join
- Previous treatment with 4 or more cycles of carboplatin;
- Previous treatment with 2 or more courses of nitrosourea or mitomycin;
- Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
- Severe and/or uncontrolled medical conditions
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
France4 sites
Novartis Investigative Site
Dijon, 21034
Novartis Investigative Site
Paris, 75005
Novartis Investigative Site
Saint-Herblain, 44805
Novartis Investigative Site
Toulouse, 31052
Canada2 sites
MD Anderson Cancer Center - Orlando
Toronto, Ontario, M5G 2M9
Novartis Investigative Site
Vancouver, British Columbia
Germany2 sites
Novartis Investigative Site
Mainz, 55101
Novartis Investigative Site
Tübingen, 72076
About this study
Official title: A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
- Conditions
- Solid Tumors
- Being tested
- gimatecan
- Keywords
- Maximum Tolerated Dose, Solid Tumors, Dose Limiting Toxicity, Topoisomerase-1 Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gimatecanDrug
| Study group | Role | What they receive |
|---|---|---|
| Daily times five schedule | Experimental | Not described Receives: Drug: gimatecan |
| Continuous schedule, twice daily | Experimental | Not described Receives: Drug: gimatecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of dose limiting toxicities in a 56-day treatment period
Measured: 56 days
Secondary outcomes (5)
safety and tolerability assessed by adverse events, serious adverse events
Measured: 112 days
pharmacokinetics of gimatecan and its metabolites(s)
Measured: 91 days
response rate assessed by anti-tumor activity
Measured: 112 days
investigate tumor-specific mutations
Measured: 57 days
Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startMar 2006
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420485
- Sponsor's protocol ID
- CLBQ707A2101
- Status last verified
- Apr 2013
- First submitted
- 8 Jan 2007
- Last updated
- 19 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00420485
- Acronym / sponsor ID
- CLBQ707A2101
- Conditions
- Solid Tumors
- Keywords
- Maximum Tolerated Dose, Solid Tumors, Dose Limiting Toxicity, Topoisomerase-1 Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Jan 2007 (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 study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily times five schedule | Experimental | Drug: gimatecan |
| Continuous schedule, twice daily | Experimental | Drug: gimatecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Advanced or metastatic cancer
- 18 years and above
Key exclusion criteria (5 listed)
- Previous treatment with 4 or more cycles of carboplatin;
- Previous treatment with 2 or more courses of nitrosourea or mitomycin;
- Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
- Severe and/or uncontrolled medical conditions
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| gimatecan | Drug | Continuous schedule, twice daily, Daily times five schedule |
Primary outcome
Presence of dose limiting toxicities in a 56-day treatment period
Time frame: 56 days
5 secondary outcomes
safety and tolerability assessed by adverse events, serious adverse events
Time frame: 112 days
pharmacokinetics of gimatecan and its metabolites(s)
Time frame: 91 days
response rate assessed by anti-tumor activity
Time frame: 112 days
investigate tumor-specific mutations
Time frame: 57 days
Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC
Time frame: 56 days
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 19 Apr 2013.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gimatecan in people with Solid Tumors, run by Novartis Pharmaceuticals at 12 sites in 7 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 2 inclusion and 5 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 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Canada, Germany, Denmark, Netherlands and 2 more countries. 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?
Presence of dose limiting toxicities in a 56-day treatment period (time frame: 56 days). 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 19 Apr 2013.