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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer

NCT00507429

Anaplastic Thyroid Cancer

TERMINATED PHASE2/PHASE3

A Study of RO6927005 Either As Monotherapy (Part A) or in Combination With Gemcitabine and Nab-Paclitaxel (Part B) to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity in Patients With Mesothelin-positive Metastatic and/or Locally Advanced Malignant Solid Tumors

NCT02317419

Cancer

TERMINATED PHASE1

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

NCT03065062

Lung Cancer Squamous Cell Solid Tumors Head & Neck Cancer +1 more

RECRUITING PHASE1

Study of Oxaliplatin and Taxotere in Prostate Cancer

NCT00260611

Prostate Cancer

COMPLETED PHASE2

Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer

NCT00560573

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anaplastic Thyroid Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1; 0.15 mg CS-7017

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.

Group Type EXPERIMENTAL

CS-7017

Intervention Type DRUG

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

Intervention Type DRUG

Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Cohort 2; 0.30 mg CS-7017

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

Group Type EXPERIMENTAL

CS-7017

Intervention Type DRUG

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

Intervention Type DRUG

Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Cohort 3; 0.50 mg CS-7017

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

Group Type EXPERIMENTAL

CS-7017

Intervention Type DRUG

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

Intervention Type DRUG

Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

Paclitaxel

Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No