Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

CancerTumorMetastasis

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS)
PFS is defined as the time from date of study Randomization to the first date of objectively determined progressive disease(PD) or death from any cause defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0).PD was defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study(including the baseline sum if that is the smallest).In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions was also considered PD.For participants still alive at the time of analysis and without evidence of tumor progression,PFS would be censored at the date of the most recent objective progression-free observation.For participants who receive subsequent anticancer therapy prior to objective disease progression or death,PFS was censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.
Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months)

Secondary Outcomes (4)

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
Baseline to Date of Tumor Response or Measured Progressive Disease or Date of Death from any Cause ((Up to 67 Months)
Overall Survival (OS)
Randomization to Date of Death from Any Cause (Up to 67 Months)
Duration of Overall Response (DOR)
Date of First Response to Date of Progressive Disease (Up to 67 Months)
Duration of Complete Response
Date of Complete Response to the Date of Progressive Disease (Up to 67 Months)

Study Arms (2)

LY2510924 + Sunitinib

EXPERIMENTAL

LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.

Drug: LY2510924Drug: Sunitinib

Sunitinib

ACTIVE COMPARATOR

50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.

Drug: Sunitinib

Interventions

LY2510924DRUG

Administered subcutaneously

LY2510924 + Sunitinib

SunitinibDRUG

Administered orally

LY2510924 + SunitinibSunitinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Evidence of histologically confirmed renal cell carcinoma (RCC) with metastases with a component of clear (conventional) cell histology
A diagnosis of metastatic renal cell carcinoma (RCC) and have not received prior treatment with systemic (adjuvant or neoadjuvant) therapy for renal cell carcinoma (RCC) (including targeted therapy such as tyrosine kinase inhibitors or bevacizumab, immunotherapy, chemotherapy, hormonal, or investigational therapy)
Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Computed tomography (CT) or magnetic resonance imaging (MRI) should be performed within 4 weeks prior to study entry
Participants who have or have not had their primary tumor removed by nephrectomy are allowed. Participants who have not had a nephrectomy should not be considered to need a nephrectomy as part of their overall therapy at the time of enrollment
Performance status score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements, to be conducted within seven days prior to treatment: (upper limit of normal/lower limit of normal \[ULN/LLN\])
hemoglobin (greater than) \>8.0 g/dL (grams per deciliter)
absolute neutrophil count (ANC) (greater than or equal to) ≥1.5 × 10\^9/L (liter)
platelet count (greater than or equal to) ≥100 × 10\^9/L (liter)
total bilirubin (less than or equal to) ≤ 1.5 × ULN (upper limit of normal)
serum creatinine (less than or equal to) ≤2 × ULN (upper limit of normal)
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (less than or equal to) ≤2.5 × ULN (upper limits of normal) \[or (less than or equal to) ≤5 × ULN (upper limits of normal) for patients with liver involvement of their cancer\]
Prothrombin Time (PT) or International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT) (less than or equal to) ≤1.5 x ULN (upper limit of normal)
For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation, hysterectomy, bilateral oophorectomy), post-menopausal (at least 12 consecutive months of amenorrhea), or have a negative pregnancy test. Women of childbearing potential should be compliant with a medically approved contraceptive regimen (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment, and must not be breastfeeding
For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
+5 more criteria

You may not qualify if:

Received prior treatment with sunitinib or LY2510924
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
History of active cardiovascular disease within the previous 12 months, including any of the following:
Myocardial infarction
Unstable angina
Coronary artery/peripheral artery bypass graft
Congestive heart failure
Malignant hypertension
Cerebrovascular accident or transient ischemic attack
Symptomatic cardiac arrhythmias (Patients with chronic, stable, rate- controlled atrial fibrillation are eligible)
Exhibit uncontrolled hypertension ( \[greater than\] \>150/100 \[millimeters of mercury\] mm/Hg despite optimal medical therapy), or history of poor compliance with antihypertensive treatment
Evidence of bleeding diathesis, National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage (less than) \<4 weeks of starting the study treatment, coagulopathy, or thromboembolic event
Significant surgery (less than) \<4 weeks of starting study treatment or a minor surgical procedure (less than) \< 7 days prior to study treatment (Placement of a portacath or other venous access device does not require a waiting period)
Suffer from medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Known or suspected allergy to any agent given in association with this trial
+5 more criteria

Contact the study team to confirm eligibility.