Solid TumorsPhase 1NCT01215916

A Phase 1 Study in Patients With Solid Tumors

A Phase 1 study testing LY573636 and Pemetrexed in people with Solid Tumors, 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

Search all trials

Trial summary

The primary objective of this study is to determine the maximum tolerated dose (MTD) regimen for the combination therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid tumor that is not amenable to curative therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: LY573636 and Pemetrexed
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Dec 2011
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

You must have a diagnosis of a solid tumor malignancy that is not amenable to curative therapy
You must have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) [30 grams per liter (g/L)]
You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drugs
Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory

Show all 10Show fewer

You must be willing to take folic acid, Vitamin B12, or prophylactic steroids
You must able to interrupt the use of aspirin (other than an aspirin dose less than or equal to 1.3 grams per day) and/or other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents, such as piroxicam)
You must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, or other investigational therapy for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). Patients who have received whole-brain radiation must wait 90 days before starting study therapy.
You must sign an informed consent

Who cannot join

You cannot have received other investigational drugs within the last 30 days
You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections
You cannot require regular, periodic paracentesis or thoracentesis
You cannot have active brain metastasis
You cannot currently be receiving warfarin (Coumadin®) therapy
You cannot be pregnant or lactating
You cannot have received prior pemetrexed or LY573636
You cannot have a second primary malignancy that could affect interpretation of the study results

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.
New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: A Phase 1b Study of LY573636-sodium in Combination With Alimta (Pemetrexed) in Patients With Solid Tumors

Conditions: Solid Tumors
Being tested: LY573636, Pemetrexed
Keywords: Solid tumors

What participants receive

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

LY573636Drug
Also called Tasisulam
Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).
Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].
PemetrexedDrug
Also called LY231514, Alimta
375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).
Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).

Study groups in NCT01215916
Study group	Role	What they receive
Experimental: Pemetrexed followed by LY573636	Experimental	Pemetrexed on Day 1 followed by LY573636 on Day 4 Receives: Drug: LY573636; Drug: Pemetrexed
Experimental: LY573636 followed by Pemetrexed	Experimental	LY573636 on Day 1, pemetrexed on Day 4 Receives: Drug: LY573636; Drug: Pemetrexed
Experimental: LY573636 and Pemetrexed on Day 1	Experimental	LY573636 and Pemetrexed on Day 1 Receives: Drug: LY573636; Drug: Pemetrexed

What is being measured

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

Recommended Phase 2 Dose
Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where <33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medication; electrolyte toxicity resolved with standard replacement treatment; alopecia; and elevated alanine aminotransferase or aspartate aminotransferase with preexisting hepatic metastasis, if agreed by investigator). Investigators, with sponsor, could declare a DLT if pt experienced increasing toxicity during treatment and it was clear that further treatment would expose pt to excessive risk. Enrollment was stopped during the dose-escalation phase, thus further dose-escalation was not explored.
Measured: Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]

Secondary outcomes (4)

Number of Participants With Clinically Significant Effects
Clinically significant effects were defined as serious and other non-serious adverse events (AEs) regardless of causality. A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
Measured: Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Percentage of Participants With a Tumor Response
Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and confirmed by repeat assessment. Complete Response (CR) was defined as the disappearance of all target lesions and the normalization of tumor marker levels for non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. Percentage of participants with a tumor response = (number of participants with CR or PR/number of enrolled participants)*100.
Measured: Baseline to progressive disease (up to 1 year of treatment plus 30-day follow-up)
Pharmacokinetics, Concentration Maximum (Cmax) of LY573636
Measured: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)
Pharmacokinetics, Area Under the Curve (AUC) of LY573636
Area under the concentration-time curve above the albumin corrected threshold (AUCalb) is provided for LY573636, which has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.
Measured: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)

Timeline

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

Feb 2008Dec 2011

First posted7 Oct 2010 (estimated)
Study startFeb 2008
Primary completionDec 2011
Study completionDec 2011

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 Solid TumorsStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215916
Sponsor's protocol ID: 11158
Other IDs: H8K-MC-JZAE
Status last verified: Dec 2018
First submitted: 5 Oct 2010
Last updated: 15 Mar 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

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 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 Alimta (Pemetrexed) in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT01215916
Acronym / sponsor ID: 11158
Conditions: Solid Tumors
Keywords: Solid tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 7 Oct 2010 (estimated)
Results: Posted 15 Mar 2019

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
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Experimental: Pemetrexed followed by LY573636	Experimental	Drug: LY573636, Drug: PemetrexedPemetrexed on Day 1 followed by LY573636 on Day 4
Experimental: LY573636 followed by Pemetrexed	Experimental	Drug: LY573636, Drug: PemetrexedLY573636 on Day 1, pemetrexed on Day 4
Experimental: LY573636 and Pemetrexed on Day 1	Experimental	Drug: LY573636, Drug: PemetrexedLY573636 and Pemetrexed on Day 1

Who may qualify

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

Key inclusion criteria (10 listed)

You must have a diagnosis of a solid tumor malignancy that is not amenable to curative therapy
You must have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) [30 grams per liter (g/L)]
You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drugs

Key exclusion criteria (8 listed)

You cannot have received other investigational drugs within the last 30 days
You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections
You cannot require regular, periodic paracentesis or thoracentesis
You cannot have active brain metastasis
You cannot currently be receiving warfarin (Coumadin®) therapy

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
LY573636Also: TasisulamIndividualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].	Drug	Experimental: LY573636 and Pemetrexed on Day 1, Experimental: LY573636 followed by Pemetrexed, Experimental: Pemetrexed followed by LY573636
PemetrexedAlso: LY231514, Alimta375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).	Drug	Experimental: LY573636 and Pemetrexed on Day 1, Experimental: LY573636 followed by Pemetrexed, Experimental: Pemetrexed followed by LY573636

Primary outcome

Recommended Phase 2 Dose
Time frame: Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]
Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where <33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medication; electrolyte toxicity resolved with standard replacement treatment; alopecia; and elevated alanine aminotransferase or aspartate aminotransferase with preexisting hepatic metastasis, if agreed by investigator). Investigators, with sponsor, could declare a DLT if pt experienced increasing toxicity during treatment and it was clear that further treatment would expose pt to excessive risk. Enrollment was stopped during the dose-escalation phase, thus further dose-escalation was not explored.

4 secondary outcomes

Number of Participants With Clinically Significant Effects
Time frame: Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Percentage of Participants With a Tumor Response
Time frame: Baseline to progressive disease (up to 1 year of treatment plus 30-day follow-up)
Pharmacokinetics, Concentration Maximum (Cmax) of LY573636
Time frame: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)
Pharmacokinetics, Area Under the Curve (AUC) of LY573636
Time frame: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)

Results and safety

Results posted to the registry on 15 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1	1	0
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1	5	0
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4	3	0
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4	6	0
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4	6	0
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4	4	0
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4	9	0
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4	3	0
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4	2	0

Primary outcome: Recommended Phase 2 Dose

Time frame: Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]

Population analysed: Enrollment was stopped during the dose-escalation phase and it was too early to assess the recommended dose for Phase 2 or to estimate the MTD, therefore zero participants were analyzed.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of study (up to 1 year of treatment plus 30-day follow-up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day1	1 of 1 (100%)	1 of 1 (100%)	Not reported
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1	4 of 5 (80%)	5 of 5 (100%)	Not reported
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4	4 of 6 (66.7%)	6 of 6 (100%)	Not reported
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4	3 of 6 (50%)	6 of 6 (100%)	Not reported
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4	3 of 4 (75%)	4 of 4 (100%)	Not reported
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4	4 of 9 (44.4%)	9 of 9 (100%)	Not reported
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4	3 of 3 (100%)	3 of 3 (100%)	Not reported
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4	2 of 2 (100%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): Enrollment was stopped early during dose-escalation phase. Original protocol dosed LY573636 and pemetrexed on Day 1; 21-day cycle. Protocol amended (due to dose limiting toxicities); LY573636 and pemetrexed doses separated by 3 days; 28-day cycle.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Solid Tumors

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma

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. 9 AM - 5 PM 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 LY573636 and Pemetrexed in people with Solid Tumors, 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 10 inclusion and 8 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 15 Mar 2019. 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 15 Mar 2019). 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 Phase 2 Dose (time frame: Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]). 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 NCT01215916.

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 15 Mar 2019.