Conditions: Solid Cancers
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 52
Healthy volunteers: no

Brief summary:
This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced solid tumors who are refractory to treatment or for whom no standard therapy exists.

Detailed description:

Arms:
arm 1: Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent. arm 2: Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.

Interventions: intervention 1: Vismodegib intervention 2: Rosiglitazone intervention 3: Norethindrone/ethinyl estradiol
Intervention descriptions: intervention 1: Vismodegib was supplied in hard gelatin capsules. intervention 2: Rosiglitazone was supplied in tablets. intervention 3: Norethindrone/ethinyl estradiol was supplied in tablets.

Protocol document: