Malignant Solid TumorsPhase 1NCT00516438
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan
A Phase 1 study testing KU-0059436 (AZD2281)(PARP inhibitor) and Topotecan in people with Malignant Solid Tumors, run by AstraZeneca at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumors
- What is being tested?
- KU-0059436 (AZD2281)(PARP inhibitor) and Topotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2007to Nov 2009
- 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
- Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
- Evaluable disease
- Adequate bone marrow, hepatic and renal function
Who cannot join
- Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study
- Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
- Co-existing active infection
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Research Site
Glasgow
Research Site
Leicester
Research Site
Manchester
About this study
Official title: A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours
- Conditions
- Malignant Solid Tumors
- Being tested
- KU-0059436 (AZD2281)(PARP inhibitor), Topotecan
- Keywords
- malignant solid tumours, Poly(ADP ribose), polymerases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KU-0059436 (AZD2281)(PARP inhibitor)Drug
Also called Olaparib
oral
TopotecanDrug
Also called Hycamtin®, Topotecan hydrochloride
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Topotecan + KU-0059436 Receives: Drug: KU-0059436 (AZD2281)(PARP inhibitor); Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan
Measured: assessed at each visit
Secondary outcomes (1)
To identify the dose limiting toxicity of the combination therapy
Measured: assessed at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KuDOS Pharmaceuticals Limited
- Investigators
- James Cassidy, Principal investigator, Beaston Oncology Centre, Glasgow, UKJames Carmichael, BSc MBChB MD FRCP, Study director, KuDOS Pharmaceutical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516438
- Sponsor's protocol ID
- KU36-93
- Other IDs
- D0810C00006
- Status last verified
- Dec 2010
- First submitted
- 13 Aug 2007
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00516438
- Acronym / sponsor ID
- KU36-93
- Conditions
- Malignant Solid Tumors
- Keywords
- malignant solid tumours, Poly(ADP ribose), polymerases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- KuDOS Pharmaceuticals Limited
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 Aug 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.
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: KU-0059436 (AZD2281)(PARP inhibitor), Drug: TopotecanTopotecan + KU-0059436 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
- Evaluable disease
- Adequate bone marrow, hepatic and renal function
Key exclusion criteria (3 listed)
- Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study
- Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
- Co-existing active infection
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 |
|---|---|---|
| KU-0059436 (AZD2281)(PARP inhibitor)Also: Olapariboral | Drug | 1 |
| TopotecanAlso: Hycamtin®, Topotecan hydrochlorideintravenous infusion | Drug | 1 |
Primary outcome
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan
Time frame: assessed at each visit
1 secondary outcome
To identify the dose limiting toxicity of the combination therapy
Time frame: assessed at each visit
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 8 Dec 2010.
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The Vanguard Study: Testing a New Way to Screen for Cancer
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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.
James Cassidy principal investigator
Beaston Oncology Centre, Glasgow, UK
James Carmichael, BSc MBChB MD FRCP study director
KuDOS Pharmaceutical Ltd
3 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 KU-0059436 (AZD2281)(PARP inhibitor) and Topotecan in people with Malignant Solid Tumors, run by AstraZeneca at 3 sites in United Kingdom.
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 3 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 8 Dec 2010. 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 United Kingdom. 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?
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan (time frame: assessed at each visit). 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 8 Dec 2010.