A Study for Participants With Metastatic Renal Cell Carcinoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2018-09-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 1 Arm A: Enzastaurin + Sunitinib

(Cohort 1): On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.

(Cohort 2): Cycle 1, Day 1 loading dose 375 mg of Enzastaurin administered po three times a day (TID), followed by 250 mg, po, BID continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.

Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) days 29-42.

Phase 2 (Part 2): Randomized Double-Blind: Dosing was determined by Part 1. Part 2 was not activated per recommendation of safety review committee.

Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6 week cycle.

Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42.

Group Type EXPERIMENTAL

Enzastaurin

Intervention Type DRUG

Administered orally

Sunitinib

Intervention Type DRUG

Administered orally

Part 2 Arm B: Sunitinib + Placebo

Part 2 was not activated per recommendation of safety review committee.

Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42.

Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, days 2-42.

Group Type PLACEBO_COMPARATOR

Sunitinib

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Enzastaurin

Administered orally

Intervention Type DRUG

Sunitinib

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY317615

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No