Phase 1
N=79
Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
Advanced Solid Tumors · Gastric Cancer · Transitional Cell Carcinoma of the Bladder
Bottom Line
View on ClinicalTrials.gov: NCT02318329 ↗Enrolled (actual)
79
Serious AEs
29.1%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- FPA144 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Five Prime Therapeutics, Inc.
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) |
1; 1; 6; 48 | — |
| SECONDARY Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration |
0.2483; 0.3117; 0.2873; 0.4097; 0.3847; 0.4900 | — |
| SECONDARY Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Response Per RECIST 1.1 (Part 2 Only) |
14.1 | — |
| SECONDARY Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve |
1.288; 1.547; 1.427; 1.863; 1.697; 2.69 | — |
Summary
This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
Eligibility Criteria
Inclusion Criteria
- Life expectancy of at least 3 months
- ECOG performance status of 0 to 1
- In sexually-active patients, willingness to use 2 effective methods of contraception
- Adequate hematological and organ function, confirmed by lab values
- Tumor tissue must be available for prospective determination of FGFR2b overexpression
- Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
- Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
- Measurable disease as defined by RECIST version 1.1
Exclusion Criteria
- Untreated or symptomatic central nervous system (CNS) metastases
- Impaired cardiac function or clinically significant cardiac disease
- Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs NCI CTCAE Grade 1
- Retinal disease or a history of retinal disease or detachment
- Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
- Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
- Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
- Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
- History of prior malignancy except:
- a) Curatively treated non-melanoma skin cancer or
- b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
- c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
- Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
Data sourced from ClinicalTrials.gov (NCT02318329). 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.