NeoplasmsPhase 1NCT00982267
A Trial Of SU14813 In Patients With Advanced Solid Malignancies
A Phase 1 study testing SU014813 in people with Neoplasms and Solid Tumors, run by Pfizer at 2 sites in 2 countries.
Trial summary
The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Solid Tumors
- What is being tested?
- SU014813
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2003to Jun 2011
- 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
- Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function
Who cannot join
- Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment
- Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy
The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.
- Conditions
- Neoplasms, Solid Tumors
- Being tested
- SU014813
- Keywords
- cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU014813Drug
Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off
| Study group | Role | What they receive |
|---|---|---|
| SU014813 | Experimental | Not described Receives: Drug: SU014813 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: 18-Nov-2008
Secondary outcomes (4)
Determine the recommended Phase 2 dose (RP2D)
Measured: 18-Nov-2008
Preliminary information on SU014813 anti-tumor effect;
Measured: 18-Nov-2008
Plasma pharmacokinetics
Measured: 18-Nov-2008
Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa
Measured: 18-Nov-2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startDec 2003
- Primary completionNov 2008
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982267
- Sponsor's protocol ID
- RTKD-7840-002
- Other IDs
- A6191002
- Status last verified
- Aug 2011
- First submitted
- 22 Sep 2009
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Fiedler W, Giaccone G, Lasch P, van der Horst I, Brega N, Courtney R, Abbattista A, Shalinsky DR, Bokemeyer C, Boven E. Phase I trial of SU14813 in patients with advanced solid malignancies. Ann Oncol. 2011 Jan;22(1):195-201. doi: 10.1093/annonc/mdq313. Epub 2010 Jul 6.
PubMed 20605934
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy
- ClinicalTrials.gov ID
- NCT00982267
- Acronym / sponsor ID
- RTKD-7840-002
- Conditions
- Neoplasms, Solid Tumors
- Keywords
- cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Sep 2009 (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 define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SU014813 | Experimental | Drug: SU014813 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function
Key exclusion criteria (2 listed)
- Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment
- Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.
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 |
|---|---|---|
| SU014813Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off | Drug | SU014813 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 18-Nov-2008
4 secondary outcomes
Determine the recommended Phase 2 dose (RP2D)
Time frame: 18-Nov-2008
Preliminary information on SU014813 anti-tumor effect;
Time frame: 18-Nov-2008
Plasma pharmacokinetics
Time frame: 18-Nov-2008
Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa
Time frame: 18-Nov-2008
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 Aug 2011.
- Derived from this study: PubMed 20605934Fiedler W, Giaccone G, Lasch P, van der Horst I, Brega N, Courtney R, Abbattista A, Shalinsky DR, Bokemeyer C, Boven E. Phase I trial of SU14813 in patients with advanced solid malignancies. Ann Oncol. 2011 Jan;22(1):195-201. doi: 10.1093/annonc/mdq313. Epub 2010 Jul 6.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 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 SU014813 in people with Neoplasms and Solid Tumors, run by Pfizer at 2 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 3 inclusion and 2 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 Aug 2011. 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 Germany, Netherlands. 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?
Maximum Tolerated Dose (MTD) (time frame: 18-Nov-2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982267, which also lists 1 linked publication.
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 Aug 2011.