Anaplastic Thyroid CancerPhase 1/2NCT00603941

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

A Phase 1/2 study testing CS-7017 and Paclitaxel in people with Anaplastic Thyroid Cancer, run by Daiichi Sankyo at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anaplastic Thyroid Cancer
What is being tested?: CS-7017 and Paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 10 sitesUnited States
Study dates: Jan 2008to Dec 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Univ of Colorado Cancer Center
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02115
Ohio State Univ
Columbus, Ohio, 43210
Mayo Clinic
Jacksonville, Florida, 32224
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
Eastern Virginia Medical School
Norfolk, Virginia, 23507
University of Pennsylvania Maloney Hospital
Philadelphia, Pennsylvania, 19104
Oregon Health Science Univ
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Washington University, Siteman Cancer Center
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel in Subjects With Advanced Anaplastic Thyroid Cancer

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.

Conditions: Anaplastic Thyroid Cancer
Being tested: CS-7017, Paclitaxel
Keywords: Anaplastic Thyroid Cancer, Neoplasm, Tumor, Anti-neoplastic Agent, First-line treatment of advanced Anaplastic thyroid cancer
Medical subject headings: Thyroid Carcinoma, Anaplastic, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00603941
Study group	Role	What they receive
Cohort 1; 0.15 mg CS-7017	Experimental	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. Receives: Drug: CS-7017; Drug: Paclitaxel
Cohort 2; 0.30 mg CS-7017	Experimental	Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks. Receives: Drug: CS-7017; Drug: Paclitaxel
Cohort 3; 0.50 mg CS-7017	Experimental	Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks. Receives: Drug: CS-7017; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From baseline up to disease progression or death, up to approximately 2 years postdose
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.
Measured: From baseline up to date of death, up to approximately 2 years postdose
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.
Measured: From baseline up to disease progression or the development of unacceptable toxicity, up to approximately 2 years postdose

Secondary outcomes (1)

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.
Measured: From baseline up to 30 days after last dose, up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Dec 2011

First posted29 Jan 2008 (estimated)
Study startJan 2008
Primary completionDec 2011
Study completionDec 2011

Why it stopped: Due to low enrollment, no participant had a dose limiting toxicity, therefore a maximum tolerated dose could not be established

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anaplastic Thyroid CancerStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00603941
Sponsor's protocol ID: CS7017-A-U103
Status last verified: Aug 2020
First submitted: 15 Jan 2008
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anaplastic Thyroid Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel in Subjects With Advanced Anaplastic Thyroid Cancer
ClinicalTrials.gov ID: NCT00603941
Acronym / sponsor ID: CS7017-A-U103
Conditions: Anaplastic Thyroid Cancer
Keywords: Anaplastic Thyroid Cancer, Neoplasm, Tumor, Anti-neoplastic Agent, First-line treatment of advanced Anaplastic thyroid cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to low enrollment, no participant had a dose limiting toxicity, therefore a maximum tolerated dose could not be established
Enrolment: 19 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 29 Jan 2008 (estimated)
Results: Posted 16 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1; 0.15 mg CS-7017	Experimental	Drug: CS-7017, Drug: PaclitaxelParticipants 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.
Cohort 2; 0.30 mg CS-7017	Experimental	Drug: CS-7017, Drug: PaclitaxelParticipants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
Cohort 3; 0.50 mg CS-7017	Experimental	Drug: CS-7017, Drug: PaclitaxelParticipants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CS-7017At 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).	Drug	Cohort 1; 0.15 mg CS-7017, Cohort 2; 0.30 mg CS-7017, Cohort 3; 0.50 mg CS-7017
PaclitaxelCommercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.	Drug	Cohort 1; 0.15 mg CS-7017, Cohort 2; 0.30 mg CS-7017, Cohort 3; 0.50 mg CS-7017

Primary outcome

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)
Time frame: From baseline up to disease progression or death, up to approximately 2 years postdose
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.
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)
Time frame: From baseline up to date of death, up to approximately 2 years postdose
Overall survival (OS) was defined as the time from the date enrollment to the date of death.
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)
Time frame: From baseline up to disease progression or the development of unacceptable toxicity, up to approximately 2 years postdose
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.

1 secondary outcome

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)
Time frame: From baseline up to 30 days after last dose, up to approximately 2 years

Results and safety

Results posted to the registry on 16 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1; 0.15 mg CS-7017	7	0
Cohort 2; 0.30 mg CS-7017	10	0
Cohort 3; 0.50 mg CS-7017	2	0

Primary outcome: 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)

Time frame: From baseline up to disease progression or death, up to approximately 2 years postdose. Median (95% Confidence Interval). Unit: days

Measure	All Patients n = 15
Value	55.5 (29.0 to 71.0)

Population analysed: PFS was assessed in the Efficacy Analysis Set. Since the study halted prematurely due to low enrollment and failed to establish a recommendation for a Phase 2 dose, it was not feasible to analyze the primary outcomes per arm. The arms were combined post hoc based on these circumstances and primary efficacy outcomes were assessed in all patients.

Primary outcome: 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)

Time frame: From baseline up to date of death, up to approximately 2 years postdose. Median (95% Confidence Interval). Unit: days

Measure	All Patients n = 15
Value	130.0 (99.0 to 142.0)

Primary outcome: 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)

Time frame: From baseline up to disease progression or the development of unacceptable toxicity, up to approximately 2 years postdose. Count of participants. Unit: Participants

Measure	All Patients n = 15
Confirmed complete response (CR)	0
Confirmed partial response (PR)	1
Objective response (confirmed CR + PR)	1
Stable disease	8
Progressive disease	4
Unknown	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1; 0.15 mg CS-7017	3 of 7 (42.9%)	6 of 7 (85.7%)	6 of 7
Cohort 2; 0.30 mg CS-7017	3 of 6 (50%)	6 of 6 (100%)	6 of 6
Cohort 3; 0.50 mg CS-7017	2 of 2 (100%)	2 of 2 (100%)	0 of 2

Limitations and caveats (from the sponsor): The study was halted prematurely due to low enrollment and failure to establish recommendation of Phase 2 dose. Analysis for the primary efficacy outcomes were also combined for the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Anaplastic Thyroid Cancer

RecruitingPhase 1
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Active, not recruitingEarly Phase 1
Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Director Clinical Development study director

Daiichi Sankyo

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CS-7017 and Paclitaxel in people with Anaplastic Thyroid Cancer, run by Daiichi Sankyo at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: From baseline up to disease progression or death, up to approximately 2 years postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.