A Phase 1 Study of LY2787106 in Cancer and Anemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01340976
First received: January 28, 2011
Last updated: March 25, 2014
Last verified: March 2014

January 28, 2011
March 25, 2014
November 2009
December 2014   (final data collection date for primary outcome measure)
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion (estimate: 4 years) ] [ Designated as safety issue: Yes ]
  • Mean change in hemoglobin with or without oral iron supplementation [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01340976 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: 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 and after last infusion on Weeks 1, 3 and 9 and/or study completion ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the curve (AUC) [ Time Frame: Days 1, 2 and 4of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 and after last infusion on Weeks 1, 3 and 9, and/or study completion ] [ Designated as safety issue: No ]
  • Recommended dose for future studies: Maximum tolerated dose (MTD) [ Time Frame: Baseline to study completion (estimate: 4 years) ] [ Designated as safety issue: Yes ]
  • Change in serum iron [ Time Frame: First dose of study drug, study completion (estimate: 4 years) ] [ Designated as safety issue: No ]
  • Maximum change in reticulocyte count [ Time Frame: First dose of study drug, study completion (estimate: 4 years) ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Baseline, Days 1, 2, 4, 8, and 15 of Cycles 1, 2, and 3, after last infusion on weeks 7, 11, and 15, and/or final visit. ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: Baseline, Days 1, 2, 4, 8, and 15 of Cycles 1, 2, and 3, after last infusion on weeks 7, 11, and 15, and/or final visit. ] [ Designated as safety issue: No ]
  • Recommended dose for future studies [ Time Frame: Baseline to study completion (estimate: 4 years) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase 1 Study of LY2787106 in Cancer and Anemia
A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Anemia
  • Drug: LY2787106
    Administered intravenously (IV).
  • Dietary Supplement: Iron Supplementation
    Administered orally.
  • Experimental: LY2787106 Dose Escalation
    Part A: Dose escalation starting at 0.3 mg/kg, intravenously (IV), day one of up to three 21-day cycles.
    Intervention: Drug: LY2787106
  • Experimental: 10 mg/kg LY2787106
    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.
    Intervention: Drug: LY2787106
  • Experimental: 10 mg/kg LY2787106+Iron
    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.
    Interventions:
    • Drug: LY2787106
    • Dietary Supplement: Iron Supplementation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
51
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 g/dL
  • Have a hepcidin level of greater than or equal to 5 ng/mL
  • Have given written informed consent prior to any study-specific procedures
  • Have adequate hematologic, hepatic, and renal organ function
  • 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

Exclusion Criteria:

  • 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 msec
  • 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)
Both
18 Years and older
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States
 
NCT01340976
13131, I3S-MC-JABA
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP