Clinical trial NCT00603941: A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel
Official title: A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel in Subjects With Advanced Anaplastic Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Anaplastic Thyroid Cancer
Keywords: Anaplastic Thyroid Cancer
Neoplasm
Tumor
Anti-neoplastic Agent
First-line treatment of advanced Anaplastic thyroid cancer
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Overall Progression-free Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
timeFrame: From baseline up to disease progression or death, up to approximately 2 years postdose
measure: Overall Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
timeFrame: From baseline up to date of death, up to approximately 2 years postdose
measure: Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
timeFrame: From baseline up to disease progression or the development of unacceptable toxicity, up to approximately 2 years postdose
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
timeFrame: From baseline up to 30 days after last dose, up to approximately 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University, Siteman Cancer Center
state: Missouri
city: Columbus
country: United States
facility: Ohio State Univ
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science Univ
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Maloney Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Daiichi Sankyo
name: Director Clinical Development
role: STUDY_DIRECTOR
References: