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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01212107 | A Phase 1 Study of LY2874455 in Participants With Advanced Cancer | PHASE1 | COMPLETED | 94 | — | — | Dec 1, 2010 | Feb 1, 2015 | Jun 12, 2019 | 3 | Australia, South Korea |
MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified.
| Arm | Type | Description |
|---|---|---|
| Part A: 2 mg FGF Receptor QD | EXPERIMENTAL | Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 4 mg FGF Receptor QD | EXPERIMENTAL | Part A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 10 mg FGF Receptor QD | EXPERIMENTAL | Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). |
| Part A: 10 mg FGF Receptor QD + Phosphate Binders | EXPERIMENTAL | Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 8 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 10 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 14 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 14 FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 18 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 24 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). |
| Part A: 18 mg FGF Receptor BID Extension | EXPERIMENTAL | Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 16 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part B: 16 mg FGF Receptor BID | EXPERIMENTAL | Part B: Dose determined by part a dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Name | Type | Description |
|---|---|---|
| FGF Receptor | DRUG | LY2874455 administered orally. |
| Phosphate Binders | DRUG | - |
Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of cancer (solid tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic and for which all standard therapies have failed * Have the presence of measurable or non-measurable disease * Have g...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520 / GEH200521 - Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |