To assess the therapeutic activity of SU11248 in patients with exptensive disease small cell lung cancer who are either chemonaive or have a sensitive relapse
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease control rate (number of CR+PR+SD) at 4 weeks
Secondary outcome
Response rate
Duration of progression free survival
Duration of response
Duration of survival
Toxicity
Background summary
Result of clinical management of patients with extensive disease small cell
lung cancer remains far from satisfactory since median survival is
approximately 9 months and virtually all patients die of disease despite all
efforts. The only way in the short term to improve upon these results is to
incorporate agents with different mechanisms of action into exisiting
combinations. It is widely demonstrated that neo-angiogenesis and its mediators
represent useful indicators of poor prognosis in SCLC. Therefore, interfering
with neo-angiogenesis is of potential interest in this malignancy. The novel
agent SU11248simultaneously inhibits KIT, PDGFR, along with VEGFR and FLT3
kinases, all being interested targets in SCLC.
Study objective
To assess the therapeutic activity of SU11248 in patients with exptensive
disease small cell lung cancer who are either chemonaive or have a sensitive
relapse
Study design
Open label non randomized multicentre phase II trial, single arm with Fleming
one stage design
Intervention
Orally administered SU11248 loading dose 150 mg followed by 37.5 mg/day
continuously
Study burden and risks
Usuaul risks associated with treatment with cytotoxic therapy. In addition, PET
scans will be performed to assess biological activity of the compound. In
consenting patients a bronchoscopy will be performed after 8 weeks of treatment
to assess effects of treatment in biopsy material and broncho-alveolar lavage.
Ave. E. Mournierlaan 83/11
Brussel 1200 Bruxelles
BE
Ave. E. Mournierlaan 83/11
Brussel 1200 Bruxelles
BE
Listed location countries
Age
Inclusion criteria
Histologically proven SCLC
Chemo naive or sensitive relapse
Measurable disease
Normal organ function
Exclusion criteria
Myocardal infarction, unstable angina, congestive heart failure, cerobrovascular accident or pulmonary embolus within 6 months
NCICTCAE grade 3 hemorrhage within 4 weeks
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002485-19-NL |
| CCMO | NL21019.029.09 |