Metastatic Renal Cell CancerPhase 1NCT01258348

A Phase 1b Trial in Patients With Renal Cell Cancer

A Phase 1 study testing Drug: LY573636-sodium and Sunitinib in people with Metastatic Renal Cell Cancer, run by Eli Lilly and Company at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Renal Cell Cancer
What is being tested?: Drug: LY573636-sodium and Sunitinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 5 sitesin 2 countries
Study dates: Jul 2008to Feb 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

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.
Indianapolis, Indiana, 46219
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.
The Woodlands, Texas, 77380

Other trials in United States

Canada1 site

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, H3T 1E2

Other trials in Canada

About this study

Official title: A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer

Conditions: Metastatic Renal Cell Cancer
Being tested: Drug: LY573636-sodium, Sunitinib
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug: LY573636-sodiumDrug
Also called Tasisulam
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.
SunitinibDrug
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.

Study groups in NCT01258348
Study group	Role	What they receive
LY573636 +sunitinib	Experimental	Not described Receives: Drug: Drug: LY573636-sodium; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Pharmacokinetics: Maximum Concentration (Cmax) of 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.
Measured: Predose up to 2 hours postdose in Cycles 1 and 2 (6 weeks per cycle)
Number of Participants With Tumor Responses
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.
Measured: Baseline to end of treatment up to 66 weeks
Sunitinib Pharmacokinetics in the Presence of LY573636: Area Under the Curve (AUC)
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.
Measured: Days 1 to 42 in Cycle 1 (6 weeks per cycle)
Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)
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.
Measured: Days 1 to 42 in Cycles 1 and Cycle 2 (6 weeks per cycle)
The Number of Participants With Clinically Significant Effects
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.
Measured: Baseline to study completion up to 70 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Feb 2012

First posted10 Dec 2010 (estimated)
Study startJul 2008
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Renal Cell CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01258348
Sponsor's protocol ID: 10407
Other IDs: H8K-MC-JZAI
Status last verified: Dec 2018
First submitted: 8 Dec 2010
Last updated: 10 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer
ClinicalTrials.gov ID: NCT01258348
Acronym / sponsor ID: 10407
Conditions: Metastatic Renal Cell Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 10 Dec 2010 (estimated)
Results: Posted 16 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY573636 +sunitinib	Experimental	Drug: Drug: LY573636-sodium, Drug: Sunitinib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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)

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug: LY573636-sodiumAlso: TasisulamParticipant 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.	Drug	LY573636 +sunitinib
Sunitinib37.5 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.	Drug	LY573636 +sunitinib

Primary outcome

Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma
Time frame: 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.

5 secondary outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Time frame: Predose up to 2 hours postdose in Cycles 1 and 2 (6 weeks per cycle)
Number of Participants With Tumor Responses
Time frame: Baseline to end of treatment up to 66 weeks
Sunitinib Pharmacokinetics in the Presence of LY573636: Area Under the Curve (AUC)
Time frame: Days 1 to 42 in Cycle 1 (6 weeks per cycle)
Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)
Time frame: Days 1 to 42 in Cycles 1 and Cycle 2 (6 weeks per cycle)
The Number of Participants With Clinically Significant Effects
Time frame: Baseline to study completion up to 70 weeks

Results and safety

Results posted to the registry on 16 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY 340 μg/mL + Sunitinib 50 mg	1	0
LY 300 μg/mL + Sunitinib 50/37.5 mg	5	0
LY 320 μg/mL + Sunitinib 37.5 mg	3	0
LY 340 μg/mL + Sunitinib 37.5 mg	6	0
LY 360 μg/mL + Sunitinib 37.5 mg	6	0

Primary outcome: Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma

Time frame: Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle). Number. Unit: micrograms per milliliter (μg/mL)

Measure	LY 340 μg/mL + Sunitinib 50 mg n = 1	LY 300 μg/mL + Sunitinib 50/37.5 mg n = 5	LY 320 μg/mL + Sunitinib 37.5 mg n = 3	LY 340 μg/mL + Sunitinib 37.5 mg n = 6	LY 360 μg/mL + Sunitinib 37.5 mg n = 6
Value	NA	NA	NA	NA	NA

Population analysed: All participants who received at least one dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY 340 μg/mL + Sunitinib 50 mg	1 of 1 (100%)	1 of 1 (100%)	Not reported
LY 300 μg/mL + Sunitinib 50/37.5 mg	2 of 5 (40%)	5 of 5 (100%)	Not reported
LY 320 μg/mL + Sunitinib 37.5 mg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
LY 340 μg/mL + Sunitinib 37.5 mg	3 of 6 (50%)	6 of 6 (100%)	Not reported
LY 360 μg/mL + Sunitinib 37.5 mg	1 of 6 (16.7%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): The primary outcome measure in this trial was not reached because the enrollment was stopped early before the maximum tolerated dose was reached.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug: LY573636-sodium and Sunitinib in people with Metastatic Renal Cell Cancer, run by Eli Lilly and Company at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma (time frame: Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01258348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.