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Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

This is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and
sunitinib as first-line therapy in participants with metastatic renal cell carcinoma,
containing 2 parts. Part 1 is a safety lead-in study with 12 participants and possible dose
escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 participants.

Inclusion Criteria:

- Participants with metastatic Renal Cell Carcinoma (RCC) who have not received prior
treatment with systemic (adjuvant or neoadjuvant) therapy for RCC (including targeted
therapy such as tyrosine kinase inhibitors or bevacizumab, immunotherapy,
chemotherapy, hormonal, or investigational therapy)

- Histologically confirmed RCC with metastases with a component of clear (conventional)
cell histology

- Evidence of unidimensional measurable disease, measured by computed tomography (CT)
scan or magnetic resonance imaging (MRI)

- Primary tumor has been surgically removed by nephrectomy or nephron-sparing surgery

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Participants must sign an informed consent document

Exclusion Criteria:

- Have received prior treatment with sunitinib or enzastaurin

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry

- Have had any of the following within 12 months prior to study drug administration:

- myocardial infarction,

- severe/unstable angina,

- coronary/peripheral artery bypass graft,

- symptomatic congestive heart failure (CHF),

- cerebrovascular accident,

- transient ischemic attack, or

- pulmonary embolism

- Note: Ongoing treatment with therapeutic doses of Coumadin® (warfarin) or a
derivative of Coumadin or phenprocoumon is not allowed, but prophylactic, low-dose
Coumadin (≤ 2 mg daily) for deep vein thrombosis is allowed. In such cases,
prothrombin time/international normalization ratio (PT/INR) should be very closely
monitored as clinically indicated

- Ongoing cardiac arrhythmias >New York Health Association Class II, atrial
fibrillation of any grade, or prolongation of the QTc interval to >450 millisecond
(msec) for males or >470 msec for females.

- Have uncontrolled hypertension [>150/100 millimeter of mercury (mm/Hg) despite
optimal medical therapy], or history of poor compliance with antihypertensive

- Require concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inducer, for example,
rifampicin or potent CYP3A inhibitors, such as ketoconazole.

- Significant surgery or radiation therapy <4 weeks of starting study treatment. Prior
palliative radiotherapy to metastatic lesion(s) is/are permitted, provided there is
at least 1 measurable lesion that has not been irradiated

- Participants who are pregnant or breast feeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Part 2: Progression Free Survival

Outcome Time Frame:

Randomization to Measured Progressive Disease (PD) (Estimated up to 24 Months)

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Austria: Ethikkommission

Study ID:




Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell