Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer

Phase 1

Completed

• Conditions: Neoplasm
• Interventions: Drug: CS-7017

• Registration Number: NCT00408434
• Lead Sponsor: Daiichi Sankyo

Brief Summary

An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential cohorts of 3 to 6 participants with advanced or metastatic malignancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-06
• Study First Posted: 2006-12-07
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2020-07-28
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Results First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Histologically or cytologically diagnosed advanced or metastatic malignancy that is refractory to, not curable with, or not eligible for standard treatment(s).
• 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grade less than or equal to 1.
• Adequate organ and bone marrow function.
• Willing to use effective contraceptive while on treatment through at least 3 months thereafter.
• Negative pregnancy test for females of childbearing potential.
• Echocardiogram with ejection fraction within normal range.

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Exclusion Criteria

• Anticipation of need for a major surgical procedure or radiation therapy during the study.
• Treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy, minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment start.
• Participants with clinically significant pleural or pericardial effusion (participants with minimal pleural effusion may be eligible at the Investigator's discretion).
• Clinically significant active infection, which requires antibiotic therapy, or human immunodeficiency virus (HIV)-positive participants receiving antiretroviral therapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS-7017	CS-7017	CS-7017 from 0.05 to 3.2 mg bid

Primary Outcome Measures

Name	Time	Method
Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies	Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 months	Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). Objective response rate was defined as the sum of all CRs and PRs.

Secondary Outcome Measures

Name	Time	Method
Summary of Pharmacokinetic Parameter Observed Maximum Plasma Concentration (Cmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies	Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.	Cmax was defined as observed maximum plasma concentration.
Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies	Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.	Area under the plasma/serum drug concentration-time curve for dosing interval (AUC\[0-tau\]), computed using the linear trapezoidal rule and area under the plasma/serum drug concentration-time curve from 0 to last time point above the quantification limit (AUC\[0-t\]) calculated using the linear trapezoidal rule were assessed.
Summary of Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies	Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.
Summary of Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies	Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.	Tmax was defined as time of maximum plasma concentration.