Phase 1
Completed N=31
Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
Neoplasm
Source: ClinicalTrials.gov NCT00408434 ↗
Enrolled (actual)
31
Serious AEs
35.5%
Results posted
Oct 2020
Primary outcomePrimary: Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
23.05; 32.05; 68.33; 59.72; 159.2; 159.14 | — |
| SECONDARY 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 |
4.21; 5.76; 12.19; 12.26; 26.92; 27.64 | — |
| SECONDARY 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 |
8.51; 13.78; 11.48; 12.49; 5.74; 9.08 | — |
| SECONDARY 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 |
3.00; 2.00; 1.58; 3.00; 2.00; 3.00 | — |
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT00408434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.