A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

Daiichi Sankyo

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Anaplastic Thyroid Cancer

Treatments: Drug: CS-7017; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00603941

CS7017-A-U103

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

During the Phase 1 and Phase 2 portions of the study, participant eligibility criteria are identical except for prior treatment for anaplastic thyroid cancer (ATC). During Phase 1, eligible participants may have received prior chemotherapy while during Phase 2, eligible participants must be chemotherapy naïve.

Inclusion Criteria:

• Histologically or cytologically diagnosed, advanced ATC
• Measurable lesion(s)
• Lesion(s) (primary or metastatic) with viable tumor tissue accessible for repeated biopsy
• Age equal to or older than 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Adequate organ and bone marrow function
• Agreement to use effective contraception while on treatment and for equal to or greater than 3 months after end of treatment
• Pregnant or breastfeeding

Exclusion Criteria:

• Medical history of diabetes mellitus requiring treatment with insulin or oral agents; no pleural or pericardial effusion or clinically significant pulmonary or cardiovascular disease.
• Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
• Clinically significant active infection requiring antibiotic or antiretroviral therapy
• Concomitant use of other thiazolidinediones (TZDs)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

19 participants in 3 patient groups

Cohort 1; 0.15 mg CS-7017

Experimental group

Description:

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.

Treatment:

Drug: Paclitaxel

Drug: CS-7017

Cohort 2; 0.30 mg CS-7017

Experimental group

Description:

Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.

Treatment:

Drug: Paclitaxel

Drug: CS-7017

Cohort 3; 0.50 mg CS-7017

Experimental group

Description:

Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.

Treatment:

Drug: Paclitaxel

Drug: CS-7017