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A Phase 1b Trial in Patients With Renal Cell Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01258348
Collaborator
(none)
21
Enrollment
5
Locations
1
Arm
43
Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine a safe dose of LY573636-sodium to be given in combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to determine any side effects that may be associated with LY573636-sodium and sunitinib combination in this patient population. The tumor response rate will also be assessed.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY573636 +sunitinib

Drug: Drug: LY573636-sodium
Participant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle. Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses. Participants may continue on treatment until clinical or objective disease progression.
Other Names:
  • Tasisulam

    • Drug: Sunitinib
    37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle. Participants may continue on treatment until clinical or objective disease progression.

    Outcome Measures

    Primary Outcome Measures

    1. Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma [Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle)]

      Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.

    Secondary Outcome Measures

    1. Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 [Predose up to 2 hours postdose in Cycles 1 and 2 (6 weeks per cycle)]

      Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.

    2. Number of Participants With Tumor Responses [Baseline to end of treatment up to 66 weeks]

      Tumor response was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Number of participants with tumor responses = number of participants with complete response (CR) + number of participants with partial response (PR). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.

    3. Sunitinib Pharmacokinetics in the Presence of LY573636: Area Under the Curve (AUC) [Days 1 to 42 in Cycle 1 (6 weeks per cycle)]

      Time frame: Cycle 1 day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.

    4. Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb) [Days 1 to 42 in Cycles 1 and Cycle 2 (6 weeks per cycle)]

      LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636. Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion. Cycle 2: predose and end of infusion.

    5. The Number of Participants With Clinically Significant Effects [Baseline to study completion up to 70 weeks]

      Clinically significant effects were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Events module.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must have a histologically confirmed diagnosis of metastatic Renal Cell Carcinoma (RCC)

    • Participants must have received no prior treatment with a cytotoxic-based chemotherapy regimen

    • Participants must have measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines

    • Have adequate hematologic, hepatic and renal function

    • Have a serum albumin level greater than equal to 3.0 grams/Liter (g/L)

    • Participants with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug

    • Exhibit participant compliance and geographic proximity that allow for adequate follow-up

    • Have given written informed consent approved by Lilly and the ethical review board (ERB)/institutional review board (IRB) governing the site

    • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy, for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy (except alopecia). Participants who have received whole-brain radiation must wait 90 days before starting study therapy

    Exclusion Criteria:

    • 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 received a prior cytotoxic chemotherapy-based systemic therapy for metastatic RCC

    • Have had any of the following within 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (CHF), cerebrovascular accident, transient ischemic attack, or pulmonary embolism

    • Ongoing cardiac arrhythmias greater than New York Health Association Class II (Protocol Attachment JZAI.4), atrial fibrillation of any grade, or prolongation of the QTc interval to greater than 450 milliseconds (msec) for males or greater than 470 msec for females

    • Have uncontrolled hypertension [greater than 150/100 millimeters of mercury (mm Hg) despite optimal medical therapy], or history of poor compliance with antihypertensive treatment

    • Participants with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry

    • Participants with serious concomitant OR pre-existing disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator)

    • Participants receiving warfarin therapy for treatment of venous thrombosis or other prothrombotic conditions

    • Participants with a second primary malignancy that could affect interpretation of the results. NOTE: Participants with adequately treated carcinoma of the skin (excluding melanoma) and participants with a prior history of malignancy who have been disease-free for greater than 2 years are eligible

    • Participants who have previously completed or withdrawn from this study or any other study investigating LY573636

    • Participants who have previously received sunitinib

    • Participants who are unable to swallow capsules

    • Participants who require concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inducers or inhibitors

    • Women who are pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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. Indianapolis Indiana United States 46219
    2 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 United States 29605
    3 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. The Woodlands Texas United States 77380
    4 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 United States 23502
    5 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. Montreal Quebec Canada H3T 1E2

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01258348
    Other Study ID Numbers:
    • 10407
    • H8K-MC-JZAI
    First Posted:
    Dec 10, 2010
    Last Update Posted:
    Jan 10, 2019
    Last Verified:
    Dec 1, 2018
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell
    Sunitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail The reasons for discontinuation listed in the Participant Flow are the reasons the participant discontinued treatment. All participants who received at least 1 dose of study drug were considered to have completed the study.
    Arm/Group Title LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Arm/Group Description LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing. LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks . LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
    Period Title: Overall Study
    STARTED 1 5 3 6 6
    Received at Least 1 Dose of Study Drug 1 5 3 6 6
    COMPLETED 0 0 0 0 0
    NOT COMPLETED 1 5 3 6 6

    Baseline Characteristics

    Arm/Group Title All Participants
    Arm/Group Description LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
    Overall Participants 21
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    61.4
    Sex: Female, Male (Count of Participants)
    Female
    6
    28.6%
    Male
    15
    71.4%
    Race/Ethnicity, Customized (Count of Participants)
    African
    2
    9.5%
    Caucasian
    17
    81%
    East Asian
    1
    4.8%
    Hispanic
    1
    4.8%
    Region of Enrollment (Count of Participants)
    United States
    21
    100%

    Outcome Measures

    1. Primary Outcome
    Title Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma
    Description Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.
    Time Frame Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug.
    Arm/Group Title LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Arm/Group Description LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing. LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks . LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
    Measure Participants 1 5 3 6 6
    Number [micrograms per milliliter (μg/mL)]
    NA
    NA
    NA
    NA
    NA
    2. Secondary Outcome
    Title Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
    Description Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.
    Time Frame Predose up to 2 hours postdose in Cycles 1 and 2 (6 weeks per cycle)

    Outcome Measure Data

    Analysis Population Description
    Participants who received study drug and had sufficient pharmacokinetic (PK) data to estimate Cmax at the specified time points.
    Arm/Group Title LY573636
    Arm/Group Description LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
    Measure Participants 21
    Cycle 1
    343.9
    (10.7)
    Cycle 2
    341.3
    (16.1)
    3. Secondary Outcome
    Title Number of Participants With Tumor Responses
    Description Tumor response was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Number of participants with tumor responses = number of participants with complete response (CR) + number of participants with partial response (PR). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
    Time Frame Baseline to end of treatment up to 66 weeks

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug.
    Arm/Group Title LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Arm/Group Description LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing. LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks . LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
    Measure Participants 1 5 3 6 6
    Count of Participants [Participants]
    0
    0%
    1
    NaN
    1
    NaN
    2
    NaN
    0
    NaN
    4. Secondary Outcome
    Title Sunitinib Pharmacokinetics in the Presence of LY573636: Area Under the Curve (AUC)
    Description Time frame: Cycle 1 day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.
    Time Frame Days 1 to 42 in Cycle 1 (6 weeks per cycle)

    Outcome Measure Data

    Analysis Population Description
    Participants who received sunitinib and had sufficient pharmacokinetic (PK) data to calculate AUC.
    Arm/Group Title Sunitinib
    Arm/Group Description LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
    Measure Participants 13
    Geometric Mean (Geometric Coefficient of Variation) [hour*nanograms per milliliter (h*ng/mL)]
    780.0
    (51.1)
    5. Secondary Outcome
    Title Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)
    Description LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636. Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion. Cycle 2: predose and end of infusion.
    Time Frame Days 1 to 42 in Cycles 1 and Cycle 2 (6 weeks per cycle)

    Outcome Measure Data

    Analysis Population Description
    Participants who received study drug and had sufficient pharmacokinetic (PK) data to calculate AUCalb at the specified time points.
    Arm/Group Title LY573636
    Arm/Group Description LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
    Measure Participants 21
    Cycle 1
    241.3
    (96.4)
    Cycle 2
    866.3
    (437.8)
    6. Secondary Outcome
    Title The Number of Participants With Clinically Significant Effects
    Description Clinically significant effects were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Events module.
    Time Frame Baseline to study completion up to 70 weeks

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug.
    Arm/Group Title LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Arm/Group Description LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing. LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks . LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
    Measure Participants 1 5 3 6 6
    Serious Adverse Events
    1
    4.8%
    2
    NaN
    2
    NaN
    3
    NaN
    1
    NaN
    Other Nonserious Adverse Events
    1
    4.8%
    5
    NaN
    3
    NaN
    6
    NaN
    6
    NaN

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Arm/Group Description LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing. LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks . LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks. LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
    All Cause Mortality
    LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/1 (100%) 2/5 (40%) 2/3 (66.7%) 3/6 (50%) 1/6 (16.7%)
    Blood and lymphatic system disorders
    Thrombocytopenia 1/1 (100%) 1 1/5 (20%) 1 1/3 (33.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1
    Gastrointestinal disorders
    Appendicitis perforated 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Constipation 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    General disorders
    Fatigue 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Mucosal inflammation 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Pyrexia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Infections and infestations
    Pneumonia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Investigations
    Haemoglobin decreased 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 0/1 (0%) 0 1/5 (20%) 2 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hyperglycaemia 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Renal and urinary disorders
    Renal failure acute 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Urinary retention 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Hypoxia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Other (Not Including Serious) Adverse Events
    LY 340 μg/mL + Sunitinib 50 mg LY 300 μg/mL + Sunitinib 50/37.5 mg LY 320 μg/mL + Sunitinib 37.5 mg LY 340 μg/mL + Sunitinib 37.5 mg LY 360 μg/mL + Sunitinib 37.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/1 (100%) 5/5 (100%) 3/3 (100%) 6/6 (100%) 6/6 (100%)
    Blood and lymphatic system disorders
    Anaemia 1/1 (100%) 1 2/5 (40%) 2 1/3 (33.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1
    Febrile neutropenia 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Leukopenia 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Lymphopenia 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Neutropenia 0/1 (0%) 0 3/5 (60%) 4 2/3 (66.7%) 3 2/6 (33.3%) 3 3/6 (50%) 6
    Thrombocytopenia 1/1 (100%) 1 3/5 (60%) 4 1/3 (33.3%) 1 2/6 (33.3%) 7 2/6 (33.3%) 2
    Cardiac disorders
    Cardiac failure congestive 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Pericardial effusion 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Tachycardia 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Eye disorders
    Eye discharge 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Eye oedema 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Eye swelling 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2
    Lacrimation increased 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Vision blurred 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Abdominal pain 0/1 (0%) 0 2/5 (40%) 3 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Abdominal pain upper 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Anal fissure 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2
    Cheilitis 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Colitis 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Constipation 0/1 (0%) 0 2/5 (40%) 3 0/3 (0%) 0 1/6 (16.7%) 1 3/6 (50%) 3
    Dental caries 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Diarrhoea 1/1 (100%) 1 4/5 (80%) 4 1/3 (33.3%) 1 4/6 (66.7%) 6 5/6 (83.3%) 5
    Dry mouth 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 2/6 (33.3%) 2 1/6 (16.7%) 1
    Dyspepsia 0/1 (0%) 0 1/5 (20%) 1 1/3 (33.3%) 1 3/6 (50%) 3 1/6 (16.7%) 1
    Faecal incontinence 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Gastrointestinal pain 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Gastrooesophageal reflux disease 0/1 (0%) 0 2/5 (40%) 2 0/3 (0%) 0 1/6 (16.7%) 1 2/6 (33.3%) 2
    Gingival bleeding 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Haemorrhoids 0/1 (0%) 0 1/5 (20%) 3 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Hiatus hernia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Nausea 1/1 (100%) 1 3/5 (60%) 4 2/3 (66.7%) 2 4/6 (66.7%) 5 4/6 (66.7%) 4
    Oral pain 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Proctalgia 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Sensitivity of teeth 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Steatorrhoea 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Stomatitis 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Vomiting 0/1 (0%) 0 1/5 (20%) 2 0/3 (0%) 0 3/6 (50%) 3 2/6 (33.3%) 4
    General disorders
    Asthenia 1/1 (100%) 2 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Catheter site pain 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Chest discomfort 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Chest pain 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Chills 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Fatigue 1/1 (100%) 1 4/5 (80%) 4 2/3 (66.7%) 2 5/6 (83.3%) 6 4/6 (66.7%) 4
    Infusion site induration 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Infusion site pain 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 2/6 (33.3%) 4
    Malaise 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Mucosal inflammation 1/1 (100%) 1 2/5 (40%) 3 0/3 (0%) 0 2/6 (33.3%) 2 2/6 (33.3%) 2
    Oedema 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Oedema peripheral 0/1 (0%) 0 1/5 (20%) 1 1/3 (33.3%) 1 3/6 (50%) 4 2/6 (33.3%) 2
    Pain 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Pyrexia 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 2/6 (33.3%) 2
    Infections and infestations
    Ear infection 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Folliculitis 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Herpes simplex 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Infection 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Oral candidiasis 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Oral herpes 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Pneumonia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Sinusitis 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Upper respiratory tract infection 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 1/6 (16.7%) 1 0/6 (0%) 0
    Aspartate aminotransferase increased 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 1/6 (16.7%) 1 0/6 (0%) 0
    Blood albumin decreased 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2
    Blood creatinine increased 0/1 (0%) 0 1/5 (20%) 1 2/3 (66.7%) 3 0/6 (0%) 0 0/6 (0%) 0
    Blood glucose increased 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood lactate dehydrogenase increased 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Haemoglobin decreased 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1
    Neutrophil count decreased 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 4 0/6 (0%) 0
    Transaminases increased 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Urine colour abnormal 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Weight decreased 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    White blood cell count decreased 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Metabolism and nutrition disorders
    Anorexia 1/1 (100%) 1 2/5 (40%) 3 1/3 (33.3%) 1 2/6 (33.3%) 2 2/6 (33.3%) 2
    Dehydration 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Hypercalcaemia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Hypercreatininaemia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Hyperglycaemia 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 3 0/6 (0%) 0 0/6 (0%) 0
    Hypomagnesaemia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Hyponatraemia 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 3 0/6 (0%) 0 0/6 (0%) 0
    Hypophosphataemia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Back pain 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 2/6 (33.3%) 2 1/6 (16.7%) 1
    Muscle spasms 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Muscular weakness 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Musculoskeletal chest pain 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Musculoskeletal pain 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Musculoskeletal stiffness 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Myalgia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 2 0/6 (0%) 0
    Neck pain 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nodule on extremity 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Pain in extremity 0/1 (0%) 0 1/5 (20%) 2 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pain in jaw 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Nervous system disorders
    Ageusia 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Dizziness 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 2/6 (33.3%) 2 0/6 (0%) 0
    Dysgeusia 0/1 (0%) 0 1/5 (20%) 1 2/3 (66.7%) 2 5/6 (83.3%) 5 4/6 (66.7%) 4
    Headache 0/1 (0%) 0 2/5 (40%) 2 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Migraine 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Neuropathy peripheral 0/1 (0%) 0 2/5 (40%) 2 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Paraesthesia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Peripheral sensory neuropathy 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Presyncope 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Tremor 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Psychiatric disorders
    Anxiety 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Insomnia 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 2/6 (33.3%) 2 0/6 (0%) 0
    Mood altered 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Renal and urinary disorders
    Incontinence 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Renal failure 1/1 (100%) 1 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1
    Urinary incontinence 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Urinary retention 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 4/6 (66.7%) 4 1/6 (16.7%) 1
    Dysphonia 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Dyspnoea 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 2/6 (33.3%) 2
    Epistaxis 1/1 (100%) 1 3/5 (60%) 5 1/3 (33.3%) 1 1/6 (16.7%) 1 2/6 (33.3%) 2
    Hiccups 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Paranasal sinus hypersecretion 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pleural effusion 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Pneumonitis 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Productive cough 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Sinus congestion 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Throat irritation 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 0/1 (0%) 0 2/5 (40%) 2 0/3 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2
    Blister 0/1 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1
    Dermatitis acneiform 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Dry skin 0/1 (0%) 0 1/5 (20%) 2 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Ecchymosis 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hair colour changes 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Nail disorder 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Palmar-plantar erythrodysaesthesia syndrome 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 2/6 (33.3%) 2
    Periorbital oedema 0/1 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pruritus 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Pruritus generalised 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Purpura 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Rash 0/1 (0%) 0 2/5 (40%) 2 0/3 (0%) 0 2/6 (33.3%) 2 1/6 (16.7%) 1
    Rash erythematous 0/1 (0%) 0 1/5 (20%) 2 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Rash maculo-papular 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Skin depigmentation 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Skin disorder 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 2 0/6 (0%) 0
    Skin exfoliation 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Skin ulcer 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Spider naevus 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Swelling face 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Vascular disorders
    Deep vein thrombosis 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Hot flush 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Hypertension 1/1 (100%) 1 0/5 (0%) 0 0/3 (0%) 0 2/6 (33.3%) 2 1/6 (16.7%) 1
    Hypotension 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Phlebitis 0/1 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2

    Limitations/Caveats

    The primary outcome measure in this trial was not reached because the enrollment was stopped early before the maximum tolerated dose was reached.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01258348
    Other Study ID Numbers:
    • 10407
    • H8K-MC-JZAI
    First Posted:
    Dec 10, 2010
    Last Update Posted:
    Jan 10, 2019
    Last Verified:
    Dec 1, 2018