SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01244438

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open-Label Phase 2 Pilot Study Evaluating the Activity and Safety of FP 1039 in Subjects With Advanced and/or Recurrent Endometrial Cancers With Specific FGFR2 Mutations

An open-label, non-randomized, single arm study to assess the safety, tolerability, and pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly starting at a dose of up to 16 mg/kg.

NCT01244438 Endometrial Cancers With FGFR2 Mutations
MeSH: Endometrial Neoplasms
HPO: Endometrial carcinoma

1 Interventions

Name: FP-1039

Description: FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.

Type: Drug

FP-1039


Primary Outcomes

Description: To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations

Measure: Response rate

Time: up to 1 year

Description: To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations

Measure: Progression-free survival

Time: 6 months

Secondary Outcomes

Description: To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer

Measure: Safety and tolerability

Time: up to 1 year

Description: To determine pharmacokinetics (PK) plasma concentration at specified times

Measure: Pharmacokinetics of Plasma

Time: up to 1 year

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 P243R

Evidence of histologically or cytologically proven metastatic or locally advanced unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation. --- S252W --- --- P243R ---


2 S252W

Evidence of histologically or cytologically proven metastatic or locally advanced unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation. --- S252W ---



HPO Nodes


HPO:
Endometrial carcinoma
Genes 19
PTEN MLH1 CDH1 PIK3CA MSH6 AKT1 POLD1 BMPR1A NTHL1 POLE SEC23B PMS2 MSH2 KLLN MSH3 SDHB SDHC SDHD GREM1