Trials Sponsors Conditions Drugs Pricing

NCT05529667

CompletedPhase 1/2

Fibroblast Growth Factor (FGFs) / Fibroblast Growth Factor R...

NCT05529667|CompletedPhase 1/2

Fibroblast Growth Factor (FGFs) / Fibroblast Growth Factor Receptor (FGFRs) Genetic as a Second-line Therapy for Recurrent / Progressive Gastric Cancer With INCB054828 and Paclitaxel a Study to Evaluate the Safety and Efficacy of Combination Therapy.

An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination With Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer With FGFs/FGFRs Genetic Aberration.

Conditions

Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel

Outcome Measures

Primary Outcomes (3)

MTD
Part 1, Phase Ib Maximum Tolerated dose (MTD)
4 weeks
Recommended phase 2 dose (RP2D)
Part 1, Phase Ib Recommended phase 2 dose as determined by Dose limiting Toxicity (DLT).
4 weeks
PFS
Prart 2, Phase II Progression-free survival (PFS): PFS is defined as the interval between the date of first dose and the earliest date of disease progression or death due to any cause.
24 weeks

Secondary Outcomes (4)

ORR
3 years
DCR
3 years
OS
3 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
3 years

Study Arms (1)

Experimental

EXPERIMENTAL

1. phase\> * INCB054828 begins with oral administration of 13.5 mg once a day. * Paclitaxel is administered intravenously every week at 80mg / m2. (Days 1, 8 and 15) It is one cycle of 4 weeks and it is administered until the time of disease progression. 2. phase\> * INCB54828 is dosed at the dose specified in phase 1. * Paclitaxel is administered intravenously every week at 80mg / m2. (Days 1, 8 and 15) It is one cycle of 4 weeks and it is administered until the time of disease progression

Drug: INCB054828, Paclitaxel

Interventions

INCB054828, PaclitaxelDrug

phase 1\> \- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. phase 2\> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent.

Experimental

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who agreed in writing to the clinical study consent
Histologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum.

Sponsors & Collaborators

Yonsei University
Otherlead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

MeSH Terms

Interventions

pemigatinibPaclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

SUN YOUNG RHA
Yonsei Cancer Center, Yonsei University College of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

September 7, 2022

Study Start

May 27, 2019

Actual (reported)

Primary Completion

Fibroblast Growth Factor (FGFs) / Fibroblast Growth Factor Receptor (FGFRs) Genetic as a Second-line Therapy for Recurrent / Progressive Gastric Cancer With INCB054828 and Paclitaxel a Study to Evaluate the Safety and Efficacy of Combination Therapy.

Fibroblast Growth Factor (FGFs) / Fibroblast Growth Factor Receptor (FGFRs) Genetic as a Second-line Therapy for Recurrent / Progressive Gastric Cancer With INCB054828 and Paclitaxel a Study to Evaluate the Safety and Efficacy of Combination Therapy.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations