Conditions: Anaplastic Thyroid Cancer
Keywords: Anaplastic Thyroid Cancer Neoplasm Tumor Anti-neoplastic Agent First-line treatment of advanced Anaplastic thyroid cancer
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 19
Healthy volunteers: no

Brief summary:
The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of the first study cycle (week 3 of combination therapy), in order to evaluate the effects of the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment will continue until disease progression or the development of intolerable toxicities.

Detailed description:

Arms:
arm 1: Participants who received 0.15 mg twice daily (BID) oral CS-7017 and 135 \[Dose Level 1a\] or 175 \[Dose Level 1b\] mg/m\^2 intravenous (IV) paclitaxel once every 3 weeks. arm 2: Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks. arm 3: Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.

Interventions: intervention 1: CS-7017 intervention 2: Paclitaxel
Intervention descriptions: intervention 1: At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.30, or 0.50 mg BID. At Phase 2, CS-7017 will be administered at the recommended phase 2 dose (RP2D). intervention 2: Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Protocol document: