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A Phase I Study of a Combination of the Proteosome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene

Phase 1
18 Years
Open (Enrolling)
Solid Tumors, Lymphoma, Multiple Myeloma

Thank you

Trial Information

A Phase I Study of a Combination of the Proteosome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene

Inclusion Criteria:

- Histologically proven advanced malignancy with measurable disease except for acute

- Progression on, or intolerance of, or ineligibility for all standard therapies

- Biopsy accessible tumor deposits

- Tumor expression of PPAR-gamma, RXR or both

- LVEF >/= institutional normal

- No evidence of clinically significant fluid retention

- ECOG Performance status 0-2

- Subjects with no brain metastases or a history of previously treated brain metastases
who have been treated with surgery or stereotactic radiosurgery at least 4 weeks
prior to enrollment and have a baseline MRI that shows no evidence of intracranial
disease and have not had treatment with steroids within one week of study enrollment.

- Adequate hepatic, bone marrow, and renal function

- Partial thromboplastin time must be 1.5. Subjects on anticoagulant will be permitted to enroll as long as the INR is in
the acceptable therapeutic range

- Life expectancy > 12 weeks

- Women of childbearing potential must have a negative serum pregnancy test within 14
days prior to initiation of treatment and/or postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential.

- Subject is capable of understanding and complying with parameters of the protocol and
able to sign and date the informed consent.

Exclusion Criteria:

- Prior CS-7017 treatment

- Treatment with thiazolidinediones (TZDs) within 4 weeks prior to start of study

- Current need for concomitant use of other TZDs during the study

- Grade 2 or greater fasting hypertriglyceridemia

- Concurrent use of insulin

- Concurrent use of known CYP 3A4 inhibiting or activating medications

- CNS metastases which do not meet the criteria outlines in inclusion criteria

- Active severe infection or known chronic infection with HIV or hepatitis B virus

- Cardiovascular disease including unstable angina, therapy for life-threatening
ventricular arrhythmia, or myocardial infarction, stroke or congestive heart failure
within the last 6 months

- Life-threatening visceral disease or other severe concurrent disease

- Women who are pregnant or breastfeeding

- Anticipated survival under 3 months

- Clinically significant and uncontrolled major medical condition(s)

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

The highest dose at which < 1 out of 6 subjects experienced a dose-limiting toxicity

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Michael Pishvaian, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Solid Tumors
  • Lymphoma
  • Multiple Myeloma
  • Advanced cancer
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Georgetown Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007