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Randomized, Multicenter, Open-label, Active-Controlled, Phase 2 Study of LY2510924 and Sunitinib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Clear Cell Renal Cell Carcinoma

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Trial Information

Randomized, Multicenter, Open-label, Active-Controlled, Phase 2 Study of LY2510924 and Sunitinib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma


Inclusion Criteria:



- 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

- Estimated life expectancy of at least 12 weeks

- Provide written informed consent/assent prior to any study-specific procedures

- No prior malignancies with the exception of stage 1 cancers definitively treated,
carcinoma in situ (any primary site), treated non-melanoma skin cancer, superficial
bladder tumors (Ta, Tis, and T1) or any cancer curatively treated 5 or more years
prior to study entry

- Capable and willing to learn to self-administer LY2510924, or have a caregiver who is
willing to learn and able to administer LY2510924 by subcutaneous (SC) injection and
are able to swallow tablets

- Left ventricular ejection fraction (LVEF) greater than or equal to LLN as defined by
the institution performing the scan, as assessed by Multiple Gated Acquisition (MUGA)
scan, or from echocardiogram to be performed within 28 days prior to start of
treatment

Exclusion Criteria:

- 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

- Prior palliative radiotherapy to metastatic lesion(s) is/are permitted, provided
there is at least 1 measurable lesion that has not been irradiated. Radiotherapy must
have been completed (greater than) >2 weeks prior to starting study treatment, and
radiation-related side effects must have resolved

- Pregnant or lactating women

- Impairment of the gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of sunitinib

- Current or recent (within 10 days of first dose of study treatment) daily use of
aspirin ( [greater than] >325 [milligram] mg/day )

- Serious nonhealing wounds, acute or nonhealing ulcers, or bone fractures

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

Baseline to measured progressive disease or date of death from any cause (approximately 2 years)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

14241

NCT ID:

NCT01391130

Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Metastatic Clear Cell Renal Cell Carcinoma
  • Cancer
  • Tumor
  • Metastasis
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Stamford, Connecticut  06902
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Jacksonville, Florida  32256
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Athens, Georgia  30607
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.St Joseph, Missouri  64507
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Las Vegas, Nevada  89169
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cherry Hill, New Jersey  08003
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cincinnati, Ohio  45267
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Tulsa, Oklahoma  74136
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenville, South Carolina  29605
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee  38138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bedford, Texas  76022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Norfolk, Virginia  23502
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Newark, Delaware  19713
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Omaha, Nebraska  68114