Phase 2
N=74
A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
Carcinoma, Renal Cell
Bottom Line
View on ClinicalTrials.gov: NCT00726323 ↗Enrolled (actual)
74
Serious AEs
56.8%
Results posted
Dec 2017
Primary outcome: Primary: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0 — 13.5; 13.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- foretinib (formerly GSK1363089 or XL880) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0 |
13.5; 13.5 | — |
| SECONDARY Disease Stabilization Rate Over Period |
91.9; 83.8 | — |
| SECONDARY Progression Free Survival (PFS) |
11.56; 9.07 | — |
| SECONDARY Time to Response (TTR) Over Period |
NA; NA | — |
| SECONDARY Duration of Response (DOR) |
20.50; 18.46 | — |
| SECONDARY Duration of Stable Disease (SD) |
12.88; 9.26 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period |
24; 21; 4; 1; 0; 1 | — |
| SECONDARY Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case) |
12; 7; 1; 0; 3; 2 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events, and Deaths |
37; 37; 20; 22; 14; 6 | — |
Summary
This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of /=25% of bone marrow within 14 days of GSK1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases,
- Any uncontrolled intercurrent illness,
- Pregnant or breastfeeding,
- HIV positive
Data sourced from ClinicalTrials.gov (NCT00726323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.