Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a "sensitive" relapse

Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a "sensitive" relapse - EORTC 08061

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33984

Enrollment

Registered

2009-03-16

Start date

2009-02-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

small cell lung cancer

Interventions

Orally administered SU11248 loading dose 150 mg followed by 37.5 mg/day continuously

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histologically proven SCLC Chemo naive or sensitive relapse Measurable disease Normal organ function

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Disease control rate (number of CR+PR+SD) at 4 weeks	—

Secondary

Measure	Time frame
Response rate Duration of progression free survival Duration of response Duration of survival Toxicity	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)