Clinical trial NCT01212107
Conditions: Advanced Cancer
Keywords: Advanced cancer Metastatic cancer Oncology
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2015-02-01
Enrollment: 94 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is to determine the recommended Phase 2 regimen of study drug that may be safely administered to participants with advanced and or metastatic cancer. The study consists of two parts: a dose escalation and a dose confirmation.

Detailed description:
Phase 1, first human dose study

Arms: arm 1: 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) arm 2: 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) arm 3: 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). arm 4: 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) arm 5: 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) arm 6: 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) arm 7: 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) arm 8: 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) arm 9: 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). arm 10: 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) arm 11: 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) arm 12: 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)
Interventions: intervention 1: FGF Receptor intervention 2: Phosphate Binders
Intervention descriptions: intervention 1: LY2874455 administered orally. intervention 2: None

Protocol documents: