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Iron

Part A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles.

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.

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.

LY2787106

Iron Supplementation

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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.

A Phase 1 Study of LY2787106 in Cancer and Anemia

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

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.

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.

Cmax is the maximum serum concentration after a single IV dose of the study drug.

AUC is the area under the concentration versus time curve from time zero to infinity.

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.

Mean change in serum iron from baseline to the end of Cycle 4.

Mean change in reticulocyte count from baseline to the end of Cycle 4.

Eli Lilly and Company

Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 0.3 mg/kg LY2787106

Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 1.0 mg/kg LY2787106

Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 3.0 mg/kg LY2787106

Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 10.0 mg/kg LY2787106

Part B: Participants received 10.0 mg/kg of LY2787106, administered IV, on day 1 of up to eight 7-day cycles.

Part B 10.0 mg/kg LY2787106

Part B: 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.

Part B 10.0 mg/kg LY2787106+Iron

Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.

Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Chief Medical Officer

Participants with at least 1 TEAE event

Participants with at least 1 SAE event

Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.

Part B 10 mg/kg LY2787106

Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.

Part B 10 mg/kg LY2787106+Iron

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

Number of Participants With Clinically Significant Events

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.

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

All participants who received at least 1 dose of study drug and who had evaluable PK data for Cmax.

Pharmacokinetics (PK): Maximum Concentration (Cmax)

All participants who received at least 1 dose of study drug and who had evaluable PK data for AUC\[0-∞\]).

PK: Area Under the Curve (AUC[0-∞])

MTD was not determined in this study, so zero participants were analyzed.

Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)

Evaluable Population in Part B is defined as a participant who has received all 4 of the first 4 per-cycle doses of study dose, 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 has had a hemoglobin assessment after each of the first 4 doses.

Change From Baseline in Serum Iron

Mean Change From Baseline in Reticulocyte Count

Part A: Participants received 0.3 mg/kg, LY2787106 intravenously (IV), day 1 of up to three 21-day cycles.

Part A 0.3 Milligram Per Kilogram (mg/kg) LY2787106

Part B: Participants received 10.0 mg/kg LY2787106, IV, on day 1 of up to eight 7-day cycles.

Spots Global Cancer Trial Database for ly2787106

Every month we try and update this database with for ly2787106 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly2787106

Every month we try and update this database with for ly2787106 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly2787106 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.