Solid TumoursPhase 1NCT00732420
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
A Phase 1 study testing topotecan and pazopanib in people with Solid Tumours, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
To determined what dose of topotecan can be safely given with daily pazopanib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- topotecan and pazopanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Sep 2008to 12 Jun 2013
- 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
- signed, written informed consent.
- at least 18 years of age.
- ECOG performance status 0 or 1.
- Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy.
- able to swallow and retain oral medications.
- females are eligible to enter and participate in this study providing adequate established contraception is being practiced.
Who cannot join
- had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
- received an investigational drug within 30 days or 5 half-lives (whichever is longer).
- received prior treatment with pazopanib/investigational anti-angiogenic compounds.
- presence of uncontrolled infection.
- pregnant or lactating.
- poorly controlled hypertension (SBP of ? 140 mmHg, or DBP of ? 90 mmHg.
Show all 14Show fewer
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.-
- arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months.
- any unresolved bowel obstruction or diarrhea ? Grade 1.
- received an allogeneic bone marrow transplant.
- known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan.
- any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study.
- psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
GSK Investigational Site
Amsterdam, 1066 CX
GSK Investigational Site
Utrecht, 3584 CX
United States1 site
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in Combination With Pazopanib in Subjects With Advanced Solid Tumors
To determined what dose of topotecan can be safely given with daily pazopanib.
Read the detailed description
A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors
- Conditions
- Solid Tumours
- Being tested
- topotecan, pazopanib
- Keywords
- pazopanib, Phase I, topotecan, Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecanDrug
Topoisomerase I inhibition.
pazopanibDrug
Tyrosine kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose. Receives: Drug: topotecan; Drug: pazopanib |
| Treatment Arm B | Experimental | Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose. Receives: Drug: topotecan; Drug: pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.
Measured: 5 weeks
Secondary outcomes (1)
Indications of efficacy through tumour shrinkage. Specific biomarker analysis.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study start24 Sep 2008
- Primary completion12 Jun 2013
- Study completion12 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732420
- Sponsor's protocol ID
- HYT109091
- Status last verified
- Nov 2017
- First submitted
- 11 Aug 2008
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in Combination With Pazopanib in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00732420
- Acronym / sponsor ID
- HYT109091
- Conditions
- Solid Tumours
- Keywords
- pazopanib, Phase I, topotecan, Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2008 (actual)
- Primary completion
- 12 Jun 2013 (actual)
- Study completion
- 12 Jun 2013 (actual)
- First posted
- 12 Aug 2008 (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.
To determined what dose of topotecan can be safely given with daily pazopanib.
Detailed description
A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: topotecan, Drug: pazopanibDaily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose. |
| Treatment Arm B | Experimental | Drug: topotecan, Drug: pazopanibDaily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed, written informed consent.
- at least 18 years of age.
- ECOG performance status 0 or 1.
- Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy.
- able to swallow and retain oral medications.
Key exclusion criteria (14 listed)
- had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
- received an investigational drug within 30 days or 5 half-lives (whichever is longer).
- received prior treatment with pazopanib/investigational anti-angiogenic compounds.
- presence of uncontrolled infection.
- pregnant or lactating.
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 |
|---|---|---|
| topotecanTopoisomerase I inhibition. | Drug | Treatment Arm A, Treatment Arm B |
| pazopanibTyrosine kinase inhibitor | Drug | Treatment Arm A, Treatment Arm B |
Primary outcome
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.
Time frame: 5 weeks
1 secondary outcome
Indications of efficacy through tumour shrinkage. Specific biomarker analysis.
Time frame: 12 weeks
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 13 Nov 2017.
- Results for study HYT109091 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
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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 study director
GlaxoSmithKline
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topotecan and pazopanib in people with Solid Tumours, run by GlaxoSmithKline at 3 sites in 2 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 6 inclusion and 14 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, 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?
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily. (time frame: 5 weeks). 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 13 Nov 2017.