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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00603941
Other study ID # CS7017-A-U103
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2008
Est. completion date December 2011

Study information

Verified date August 2020
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
CS-7017
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).
Paclitaxel
Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Locations

Country Name City State
United States Univ of Colorado Cancer Center Aurora Colorado
United States Massachusetts General Hospital Boston Massachusetts
United States Ohio State Univ Columbus Ohio
United States Mayo Clinic Jacksonville Florida
United States Vanderbilt Ingram Cancer Center Nashville Tennessee
United States Eastern Virginia Medical School Norfolk Virginia
United States University of Pennsylvania Maloney Hospital Philadelphia Pennsylvania
United States Oregon Health Science Univ Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States Washington University, Siteman Cancer Center Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions. From baseline up to disease progression or death, up to approximately 2 years postdose
Primary 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) Overall survival (OS) was defined as the time from the date enrollment to the date of death. From baseline up to date of death, up to approximately 2 years postdose
Primary 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) The best overall response was the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no tumor assessment after the date of enrollment, the best overall response is classified as Unknown. From baseline up to disease progression or the development of unacceptable toxicity, up to approximately 2 years postdose
Secondary 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) Treatment-emergent adverse events (TEAEs) are defined as adverse events that started or worsened after the first dose of any study drug (after Day 1 or first day of CS-7017 monotherapy) but adverse events occurring more than 30 days after the last dose are not considered TEAEs unless also considered to be related (possibly, probably, or definitely) to study drug. From baseline up to 30 days after last dose, up to approximately 2 years
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