A Study for Participants With Metastatic Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Enzastaurin; Sunitinib; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in
      metastatic Renal Cell Cancer.
    

Eligibility criteria:

        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 treatment

          -  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