AnemiaPhase 1NCT01340976

A Phase 1 Study of LY2787106 in Cancer and Anemia

A Phase 1 study testing LY2787106 and Iron Supplementation in people with Anemia, run by Eli Lilly and Company at 9 sites 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

This study will evaluate the safety LY2787106 in participants with cancer and anemia. It will also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a dose escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given with and without iron supplementation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: LY2787106 and Iron Supplementation
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 9 sitesUnited States
Study dates: Jan 2010to Dec 2014
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

Have histological or cytological evidence of non-myeloid cancer (solid tumors, lymphomas or multiple myeloma) that is metastatic and/or incurable
Have been treated with at least one systemic (oral, intravenous, or subcutaneous) anti-cancer therapy or regimen
Have a hemoglobin of less than or equal to 11 grams/deciliter (g/dL)
Have a hepcidin level of greater than or equal to 5 nanograms/milliliter (ng/mL)
Have given written informed consent prior to any study-specific procedures
Have adequate hematologic, hepatic, and renal organ function

Show all 11Show fewer

Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Available for the duration of the study and willing to follow study procedures
If male or female with reproductive potential: Must agree to use medically approved contraception during the trial and for 4 months following the last dose of study drug
If female with child bearing potential: Have a negative serum pregnancy test
Have an estimated life expectancy of greater than or equal to 12 weeks

Who cannot join

Have received treatment in the previous 21 days with, or have not recovered fully from, a drug that has not received regulatory approval for any indication
Have received erythropoiesis-stimulating agents in the previous 21 days or red blood cell transfusions in the previous 14 days, or in the investigator's opinion, likely to need red blood cell transfusion more frequently than every 21 days
Have received parenteral iron supplementation within the prior 14 days
Have a documented history of pure red cell aplasia, thalassemia major or sickle cell disease
Have a history of cirrhosis or major organ transplantation
QTc greater than 470 millisecond (msec)

Show all 18Show fewer

Have evidence of clinically significant hemolysis or bleeding
Have a clinically significant systemic infection within 14 days of enrollment
Have a suspected or confirmed history of hemochromatosis.
Have other serious preexisting medical conditions (left to the discretion of the investigator)
Have symptomatic central nervous system malignancy or metastasis (screening not required)
Have acute or chronic leukemia
Are a female who is pregnant or lactating
Have a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (screening not required)
Have received external beam radiotherapy to more than 25% of the bone marrow
Have known clinically significant hypersensitivity to biologic agents
Have received live vaccine(s) within 1 month of screening or with plans of doing that during the participation to the study
Have a history of congestive heart failure with New York Heart Association (NYHA) Class greater than 2 (NYHA Class 1 and 2 are eligible), unstable angina or recent myocardial infarction (within 1 year prior to administration of study drug)

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 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.
Dallas, Texas, 75246
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.
Houston, Texas, 77030
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, 46202
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.
La Jolla, California, 92093
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.
Philadelphia, Pennsylvania, 19106
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.
Santa Monica, California, 90404
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.
Seattle, Washington, 98109
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
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.
Vancouver, Washington, 98684

Other trials in United States

About this study

Official title: A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia

Conditions: Anemia
Being tested: LY2787106, Iron Supplementation
Keywords: Cancer Related Anemia
Medical subject headings: Anemia

What participants receive

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

LY2787106Drug
Administered IV.
Iron SupplementationDietary supplement
Administered orally.

Study groups in NCT01340976
Study group	Role	What they receive
LY2787106 Dose Escalation	Experimental	Part A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles. Receives: Drug: LY2787106
10 mg/kg LY2787106	Experimental	Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator. Receives: Drug: LY2787106
10 mg/kg LY2787106+Iron	Experimental	Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles with daily oral iron supplementation. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator. Receives: Drug: LY2787106; Dietary Supplement: Iron Supplementation

What is being measured

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

Number of Participants With Clinically Significant Events
Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Measured: Baseline to Study Completion (up to 5 Years)
Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation
This analysis assesses the mean change in Hemoglobin from baseline to the end of Cycle 4. The analysis was carried separately for Cohort B1 without supplemental iron and Cohort B2 with supplemental iron.
Measured: Baseline, Cycle 4 (7-day cycle)

Secondary outcomes (5)

Pharmacokinetics (PK): Maximum Concentration (Cmax)
Cmax is the maximum serum concentration after a single IV dose of the study drug.
Measured: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion
PK: Area Under the Curve (AUC[0-∞])
AUC is the area under the concentration versus time curve from time zero to infinity.
Measured: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion
Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)
MTD is defined as being the highest tested dose below the level at which one-third or more of participants experience a Dose-limiting toxicity (DLT). DLT is defined as an adverse event occurring in any part of the study that is related to the study medication, occurs during Cycle 1 of Part A, and fulfills any one of the following criteria:
1. Clinically significant Grade 2 toxicity, such as angina, arrhythmia, seizure, dyspnea, rash with significant blistering or desquamation, or other event deemed significant by either the investigator.
2. ≥Grade 3 anemia (excluding participants with baseline <9.0 g/dL) or hemoglobin (Hb) decrease >1.0 g/dL if baseline Hb <9.0 g/dL, confirmed by 2 independent measurements.
3. ≥ Grade 3 cytokine release syndrome/acute infusion reaction.
4. Other ≥ Grade 3 hematological or non-hematological toxicity.
Measured: Baseline to Cycle 1 of Part A
Change From Baseline in Serum Iron
Mean change in serum iron from baseline to the end of Cycle 4.
Measured: Baseline, Cycle 4 (7-day cycle)
Mean Change From Baseline in Reticulocyte Count
Mean change in reticulocyte count from baseline to the end of Cycle 4.
Measured: Baseline, Cycle 4 (7-day cycle)

Timeline

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

Jan 2010Dec 2014

First posted25 Apr 2011 (estimated)
Study startJan 2010
Primary completionDec 2014
Study completionDec 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies 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: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340976
Sponsor's protocol ID: 13131
Other IDs: I3S-MC-JABA
Status last verified: Feb 2018
First submitted: 28 Jan 2011
Last updated: 3 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vadhan-Raj S, Abonour R, Goldman JW, Smith DA, Slapak CA, Ilaria RL Jr, Tiu RV, Wang X, Callies S, Cox J, Tuttle JL, Lau YK, Roeland EJ. A first-in-human phase 1 study of a hepcidin monoclonal antibody, LY2787106, in cancer-associated anemia. J Hematol Oncol. 2017 Mar 21;10(1):73. doi: 10.1186/s13045-017-0427-x.
PubMed 28327200

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 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia
ClinicalTrials.gov ID: NCT01340976
Acronym / sponsor ID: 13131
Conditions: Anemia
Keywords: Cancer Related Anemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 25 Apr 2011 (estimated)
Results: Posted 3 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: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LY2787106 Dose Escalation	Experimental	Drug: LY2787106Part A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles.
10 mg/kg LY2787106	Experimental	Drug: LY2787106Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.
10 mg/kg LY2787106+Iron	Experimental	Drug: LY2787106, Dietary Supplement: Iron SupplementationPart B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles with daily oral iron supplementation. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.

Who may qualify

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

Key inclusion criteria (11 listed)

Have histological or cytological evidence of non-myeloid cancer (solid tumors, lymphomas or multiple myeloma) that is metastatic and/or incurable
Have been treated with at least one systemic (oral, intravenous, or subcutaneous) anti-cancer therapy or regimen
Have a hemoglobin of less than or equal to 11 grams/deciliter (g/dL)
Have a hepcidin level of greater than or equal to 5 nanograms/milliliter (ng/mL)
Have given written informed consent prior to any study-specific procedures

Key exclusion criteria (18 listed)

Have received treatment in the previous 21 days with, or have not recovered fully from, a drug that has not received regulatory approval for any indication
Have received erythropoiesis-stimulating agents in the previous 21 days or red blood cell transfusions in the previous 14 days, or in the investigator's opinion, likely to need red blood cell transfusion more frequently than every 21 days
Have received parenteral iron supplementation within the prior 14 days
Have a documented history of pure red cell aplasia, thalassemia major or sickle cell disease
Have a history of cirrhosis or major organ transplantation

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
LY2787106Administered IV.	Drug	10 mg/kg LY2787106, 10 mg/kg LY2787106+Iron, LY2787106 Dose Escalation
Iron SupplementationAdministered orally.	Dietary supplement	10 mg/kg LY2787106+Iron

Primary outcome

Number of Participants With Clinically Significant Events
Time frame: Baseline to Study Completion (up to 5 Years)
Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation
Time frame: Baseline, Cycle 4 (7-day cycle)
This analysis assesses the mean change in Hemoglobin from baseline to the end of Cycle 4. The analysis was carried separately for Cohort B1 without supplemental iron and Cohort B2 with supplemental iron.

5 secondary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax)
Time frame: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion
PK: Area Under the Curve (AUC[0-∞])
Time frame: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion
Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)
Time frame: Baseline to Cycle 1 of Part A
Change From Baseline in Serum Iron
Time frame: Baseline, Cycle 4 (7-day cycle)
Mean Change From Baseline in Reticulocyte Count
Time frame: Baseline, Cycle 4 (7-day cycle)

Results and safety

Results posted to the registry on 3 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
Part A 0.3 Milligram Per Kilogram (mg/kg) LY2787106	4	0
Part A 1.0 mg/kg LY2787106	3	1
Part A 3.0 mg/kg LY2787106	7	4
Part A 10.0 mg/kg LY2787106	5	2
Part B 10.0 mg/kg LY2787106	7	5
Part B 10.0 mg/kg LY2787106+Iron	7	6

Primary outcome: Number of Participants With Clinically Significant Events

Time frame: Baseline to Study Completion (up to 5 Years). Number. Unit: participants

Measure	Part A 0.3 mg/kg LY2787106 n = 4	Part A 1.0 mg/kg LY2787106 n = 3	Part A 3.0 mg/kg LY2787106 n = 7	Part A 10.0 mg/kg LY2787106 n = 5	Part B 10 mg/kg LY2787106 n = 7	Part B 10 mg/kg LY2787106+Iron n = 7
Participants with at least 1 TEAE event	4	3	6	5	0	0
Participants with at least 1 SAE event	1	2	2	0	0	1

Population analysed: All participants who received at least 1 dose of study drug.

Primary outcome: Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation

Time frame: Baseline, Cycle 4 (7-day cycle). Mean (Standard Deviation). Unit: grams per deciliter (g/dL)

Measure	Part B 10 mg/kg LY2787106 n = 6	Part B 10 mg/kg LY2787106+Iron n = 6
Value	-0.5 (0.49)	-0.2 (0.80)

Population analysed: Evaluable population in Part B is defined as a participant who received all 4 of the first 4 per-cycle doses of study medication, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who had a hemoglobin assessment after each of the first 4 doses.

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
Part A 0.3 mg/kg LY2787106	1 of 4 (25%)	4 of 4 (100%)	Not reported
Part A 1.0 mg/kg LY2787106	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Part A 3.0 mg/kg LY2787106	2 of 7 (28.6%)	6 of 7 (85.7%)	Not reported
Part A 10.0 mg/kg LY2787106	0 of 5 (0%)	5 of 5 (100%)	Not reported
Part B 10.0 mg/kg LY2787106	0 of 7 (0%)	7 of 7 (100%)	Not reported
Part B 10.0 mg/kg LY2787106+Iron	1 of 7 (14.3%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28327200Vadhan-Raj S, Abonour R, Goldman JW, Smith DA, Slapak CA, Ilaria RL Jr, Tiu RV, Wang X, Callies S, Cox J, Tuttle JL, Lau YK, Roeland EJ. A first-in-human phase 1 study of a hepcidin monoclonal antibody, LY2787106, in cancer-associated anemia. J Hematol Oncol. 2017 Mar 21;10(1):73. doi: 10.1186/s13045-017-0427-x.

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

Eli Lilly and Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2787106 and Iron Supplementation in people with Anemia, run by Eli Lilly and Company at 9 sites 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 11 inclusion and 18 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 3 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 9 sites 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 3 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 Clinically Significant Events (time frame: Baseline to Study Completion (up to 5 Years)). The study lists 2 primary outcomes in all. 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 NCT01340976, which also lists 1 linked publication.

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 3 Oct 2018.