CancerPhase 1NCT00415636

Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer

A Phase 1 study testing IC83/LY2603618 and pemetrexed in people with Cancer, run by Eli Lilly and Company at 1 site in United States.

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 evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: IC83/LY2603618 and pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Jul 2010
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

Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
Has fully recovered from all toxicities due to the following:
Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
Surgery.
Has a life expectancy of at least 3 months.
Negative serum pregnancy test.

Who cannot join

Is pregnant or breastfeeding.
Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
Has a known active infection.

Trial locations and contacts

1 site in 1 country.

United States1 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.
Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer

The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.

Conditions: Cancer
Being tested: IC83/LY2603618, pemetrexed
Medical subject headings: Neoplasms

What participants receive

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

IC83/LY2603618Drug
40 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m^2.
IC83/LY2603618Drug
70 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
IC83/LY2603618Drug
105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
IC83/LY2603618Drug
150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
IC83/LY2603618Drug
195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
pemetrexedDrug
Also called Alimta, LY231514
pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
pemetrexedDrug
pemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles

Study groups in NCT00415636
Study group	Role	What they receive
LY2603618 40 mg/m^2 (4.5-hour infusion)	Experimental	LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed. Receives: Drug: IC83/LY2603618; Drug: pemetrexed
LY2603618 40 mg/m^2 (1-hour infusion)	Experimental	Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), the LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed. Receives: Drug: IC83/LY2603618; Drug: pemetrexed
LY2603618 70 mg/m^2	Experimental	Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour. Receives: Drug: IC83/LY2603618; Drug: pemetrexed
LY2603618 105 mg/m^2	Experimental	Cohort 4: LY2603618 105 mg/m^2 administered over the duration of 1 hour. Receives: Drug: IC83/LY2603618; Drug: pemetrexed
LY2603618 150 mg/m^2	Experimental	Cohort 5: LY2603618 150 mg/m^2 administered over the duration of 1 hour. Receives: Drug: IC83/LY2603618; Drug: pemetrexed
LY2603618 195 mg/m^2	Experimental	Cohort 6: LY2603618 195 mg/m^2 administered over the duration of 1 hour. Receives: Drug: IC83/LY2603618; Drug: pemetrexed

What is being measured

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

Number of Participants With Adverse Events (AEs)
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Measured: baseline up to 24 months

Secondary outcomes (3)

Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.
Measured: Day 1 and Day 9 of Cycle 1
Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
AUC[0-∞] was calculated from the plasma concentration data of LY2603618 versus time profiles.
Measured: Day 1 and Day 9 of Cycle 1
Percentage of Participants With Best Overall Response
Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm * 100.
Measured: baseline up to 24 months

Timeline

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

Jan 2007Jul 2010

First posted25 Dec 2006 (estimated)
Study startJan 2007
Primary completionMar 2010
Study completionJul 2010

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 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
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00415636
Sponsor's protocol ID: 11911
Other IDs: I2I-MC-JMMB
Status last verified: Mar 2018
First submitted: 21 Dec 2006
Last updated: 19 Oct 2018
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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
ClinicalTrials.gov ID: NCT00415636
Acronym / sponsor ID: 11911
Conditions: Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Mar 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 25 Dec 2006 (estimated)
Results: Posted 19 Oct 2018

Clinical summary

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

The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
LY2603618 40 mg/m^2 (4.5-hour infusion)	Experimental	Drug: IC83/LY2603618, Drug: pemetrexedLY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
LY2603618 40 mg/m^2 (1-hour infusion)	Experimental	Drug: IC83/LY2603618, Drug: pemetrexedBased on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), the LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
LY2603618 70 mg/m^2	Experimental	Drug: IC83/LY2603618, Drug: pemetrexedBeginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
LY2603618 105 mg/m^2	Experimental	Drug: IC83/LY2603618, Drug: pemetrexedCohort 4: LY2603618 105 mg/m^2 administered over the duration of 1 hour.
LY2603618 150 mg/m^2	Experimental	Drug: IC83/LY2603618, Drug: pemetrexedCohort 5: LY2603618 150 mg/m^2 administered over the duration of 1 hour.
LY2603618 195 mg/m^2	Experimental	Drug: IC83/LY2603618, Drug: pemetrexedCohort 6: LY2603618 195 mg/m^2 administered over the duration of 1 hour.

Who may qualify

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

Key inclusion criteria (6 listed)

Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
Has fully recovered from all toxicities due to the following:
Has a life expectancy of at least 3 months.
Negative serum pregnancy test.

Key exclusion criteria (5 listed)

Is pregnant or breastfeeding.
Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
Has a known active infection.

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
IC83/LY260361840 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m^2.	Drug	LY2603618 40 mg/m^2 (1-hour infusion), LY2603618 40 mg/m^2 (4.5-hour infusion)
IC83/LY260361870 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.	Drug	LY2603618 70 mg/m^2
IC83/LY2603618105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.	Drug	LY2603618 105 mg/m^2
IC83/LY2603618150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.	Drug	LY2603618 150 mg/m^2
IC83/LY2603618195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.	Drug	LY2603618 195 mg/m^2
pemetrexedAlso: Alimta, LY231514pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles	Drug	LY2603618 40 mg/m^2 (4.5-hour infusion)
pemetrexedpemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles	Drug	LY2603618 105 mg/m^2, LY2603618 150 mg/m^2, LY2603618 195 mg/m^2, LY2603618 40 mg/m^2 (1-hour infusion), LY2603618 70 mg/m^2

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: baseline up to 24 months
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.

3 secondary outcomes

Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Time frame: Day 1 and Day 9 of Cycle 1
Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
Time frame: Day 1 and Day 9 of Cycle 1
Percentage of Participants With Best Overall Response
Time frame: baseline up to 24 months

Results and safety

Results posted to the registry on 19 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
LY2603618 40 mg/m^2 (4.5-hour Infusion)	3	2
LY2603618 40 mg/m^2 (1-hour Infusion)	3	3
LY2603618 70 mg/m^2	3	2
LY2603618 105 mg/m^2	13	7
LY2603618 150 mg/m^2	6	4
LY2603618 195 mg/m^2	3	1

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: baseline up to 24 months. Count of participants. Unit: Participants

Measure	LY2603618 40 mg/m^2 (4.5-hour Infusion) n = 3	LY2603618 40 mg/m^2 (1-hour Infusion) n = 3	LY2603618 70 mg/m^2 n = 3	LY2603618 105 mg/m^2 n = 13	LY2603618 150 mg/m^2 n = 6	LY2603618 195 mg/m^2 n = 3
Other Non-Serious Adverse Events (AEs)	3	3	3	13	6	3
Serious Adverse Events (SAEs)	1	0	2	8	4	2

Population analysed: The safety population was comprised of all participants who received any amount of LY2603618.

3 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
LY2603618 40 mg/m^2 (4.5-hour Infusion)	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
LY2603618 40 mg/m^2 (1-hour Infusion)	0 of 3 (0%)	3 of 3 (100%)	Not reported
LY2603618 70 mg/m^2	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
LY2603618 105 mg/m^2	8 of 13 (61.5%)	13 of 13 (100%)	Not reported
LY2603618 150 mg/m^2	4 of 6 (66.7%)	6 of 6 (100%)	Not reported
LY2603618 195 mg/m^2	2 of 3 (66.7%)	3 of 3 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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-5PM Eastern time (UTC/GMT-5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IC83/LY2603618 and pemetrexed in people with Cancer, run by Eli Lilly and Company at 1 site in United States.

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 6 inclusion and 5 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 19 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?

Number of Participants With Adverse Events (AEs) (time frame: baseline up to 24 months). 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 NCT00415636.

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 19 Oct 2018.