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 - ND

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10050018Term: Renal cancer metastatic; metastatic renal cell carcinoma

• Registration Number: EUCTR2007-003847-66-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Patients with metastatic 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) 2. Histologically confirmed RCC with metastases with a component of clear (conventional) cell histology 3. Evidence of unidimensionally measurable disease (≥1 malignant tumor mass that can be accurately measured in at least 1 dimension ≥20 mm with conventional computed tomography (CT) or magnetic resonance imaging (MRI) scan, or ≥10 mm with spiral CT scan. (If spiral CT scan is used, minimum lesion size should be twice the reconstruction interval used. For example, if reconstruction size is 7 mm, lesion size should be ≥14 mm). CT/MRI should be performed within 4 weeks prior to study entry Note: Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable. 4. Primary tumor has been surgically removed by nephrectomy or nephron-sparing surgery 5. ECOG performance status score of 0 or 1 6. Have adequate bone marrow, liver, and renal function 7. Patients must be at least 18 years of age 8.Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment, based on either a serum or urine pregnancy test. Both male and female patients of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and his or her health-care team, during the study and for 3 months following the last dose of study treatment 9. No prior malignancies for ≥5 years with the exception of cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated ≥5 years prior to study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Have received prior treatment with sunitinib or enzastaurin
2. Have history of or known brain metastases, spinal cord compression,
carcinomatous meningitis, or evidence of brain or leptomeningeal
disease on screening CT or MRI scan
3. Have history of documented central nervous system disease unrelated
to cancer; for example, uncontrolled seizures, unless adequately
treated with standard medical therapy
4.Have evidence of bleeding diathesis, NCI CTCAE Grade 3
hemorrhage <4 weeks of starting the study treatment, coagulopathy, or
thromboembolic event
5.Have uncontrolled hypertension (>150/100 mm/Hg despite optimal
medical therapy), or history of poor compliance with antihypertensive
treatment.
6. Require concomitant use of potent CYP3A4 inducer, for example,
rifampicin or potent CYP3A inhibitors, such as ketoconazole.
Note: Protocol Attachment S061.4 provides an extensive list of
CYP3A4 inhibitors or inducers.
7. Have impairment of the gastrointestinal (GI) function or GI disease
that may significantly alter the absorption of study drug.
8. Current or recent (within 10 days of first dose of study treatment) daily
use of aspirin (>325 mg/day)
9.Patients who are pregnant or breast feeding.
10. Have any condition that is unstable or which could jeopardize the
safety of the patient and his/her compliance in the study (for example,
uncontrolled diabetes mellitus, pancreatitis, acute or chronic liver
disease), and preexisting thyroid abnormality with thyroid function
that cannot be maintained in the normal range with medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified