Pazopanib Maintenance for SCLC

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: SCLC

Treatments: Drug: Pazopanib; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01797874

2012-09-060-002

Details and patient eligibility

About

To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.

Enrollment: 97 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed SCLC
• no disease progression after 4 cycles of etoposide/platinum 1st-line therapy
• history of 4 cycles of etoposide/platinum 1st-line therapy
• between 21 days and 42 days since C4D1 of etoposide/platinum
• no symptomatic brain meta

Exclusion criteria

• poor hepatic, renal function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 2 patient groups, including a placebo group

Pazopanib

Experimental group

Description:

pazopanib maintenance after 4 cycles of etoposide/platinum in SCLC

Treatment:

Drug: Pazopanib

placebo

Placebo Comparator group

Description:

placebo after 4 cycles of etoposide/platinum chemotherapy in SCLC

Treatment:

Drug: Placebo