Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01340976 | A Phase 1 Study of LY2787106 in Cancer and Anemia | PHASE1 | COMPLETED | 33 | — | — | Jan 1, 2010 | Dec 1, 2014 | Oct 3, 2018 | 9 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| LY2787106 | DRUG | Administered IV. |
| Iron Supplementation | DIETARY_SUPPLEMENT | Administered orally. |
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 hemoglo...