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An Open-label Phase I Study of Orally Available Novel Small-molecule Fibroblast Growth Factor Receptors (FGFR) 1,2,3 and 4 Inhibitor, ASP5878 at Single and Multiple Doses in Patients With Solid Tumors

NCT ID: NCT02038673

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-05

Study Completion Date

2017-07-19

Brief Summary

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The objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors.

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Detailed Description

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This study consists of two parts. In the dose-escalation part, ASP5878 (orally available novel small-molecule FGFR 1,2,3 and 4 inhibitor, multiple dosing once-a-day (q.d.), multiple dosing twice-a-day (b.i.d.) or 5-day on/2-day off dosing twice-a-day (5on-2off)) is administered to participants with solid tumors in an increasing dose manner, and the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ASP5878 are evaluated in these participants. Cycle 0 consists of 3 days and Cycle 1 and subsequent cycles consist of 28 days each in the dose-escalation part. In the expansion part, 16mg twice-a-day 5-day on/2-day off dose of ASP5878 (5on-2off) is administered to participants with solid tumors and safety, PK, PD and efficacy of ASP5878 are evaluated. The expansion part starts from Cycle 1 and each cycle consists of 28 days.

Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation part 0.5 mg QD

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 1.0 mg QD

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 2.0 mg QD

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 2.0 mg BID

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 4.0 mg BID

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 6.0 mg BID

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 10.0 mg BID

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 20.0 mg BID

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Dose escalation part 16.0 mg BID

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Expansion part Urothelial Carcinoma

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Expansion part Hepatocellular Carcinoma

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Expansion part Squamous Cell Lung Carcinoma

Oral

Group Type EXPERIMENTAL

ASP5878

Intervention Type DRUG

oral

Interventions

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ASP5878

oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed solid tumor.
* Participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator:

* Disease progression despite standard therapies
* Progressive disease without any standard therapies established
* Standard therapies are considered intolerable
* Eastern Cooperative Oncology Group performance status 0 or 1.
* Predicted life expectancy ≥ 12 weeks in the judgment of the investigator or sub-investigator.

Exclusion Criteria

* Participant with ≥ Grade 2 (CTCAE v 4.0-JCOG) persistent symptoms and objective findings due to the toxicity attributable to prior treatment with antitumor effect (except alopecia).
* Participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin C or Nitrosourea within 6 weeks prior to the planned first day of study drug dosing).
* A major surgical procedure within 4 weeks prior to the planned first day of study drug dosing or a surgical procedure is planned during the course of the study.
* Participant who were treated with other investigational drug or medical device within 4 weeks prior to the planned first day of study drug dosing.
* Participant who has a history of organ transplantation.
* Participant with a brain metastasis with symptoms or requiring treatment.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Site US402

Orange, California, United States

Site Status

Site US401

New York, New York, United States

Site Status

Site US404

Cleveland, Ohio, United States

Site Status

Site US406

Spartanburg, South Carolina, United States

Site Status

Site US410

Fairfax, Virginia, United States

Site Status

Site US403

Seattle, Washington, United States

Site Status

Site JP122

Chiba, , Japan

Site Status

Site JP108

Fukuoka, , Japan

Site Status

Site JP115

Fukuoka, , Japan

Site Status

Site JP120

Fukuoka, , Japan

Site Status

Site JP116

Hokkaido, , Japan

Site Status

Site JP113

Hyōgo, , Japan

Site Status

Site JP103

Ibaraki, , Japan

Site Status

Site JP111

Ishikawa, , Japan

Site Status

Site JP119

Kanagawa, , Japan

Site Status

Site JP101

Kyoto, , Japan

Site Status

Site JP109

Miyagi, , Japan

Site Status

Site JP110

Miyagi, , Japan

Site Status

Site JP112

Nagoya, , Japan

Site Status

Site JP117

Niigata, , Japan

Site Status

Site JP121

Okayama, , Japan

Site Status

Site JP104

Osaka, , Japan

Site Status

Site JP106

Osaka, , Japan

Site Status

Site JP118

Osaka, , Japan

Site Status

Site JP124

Shizuoka, , Japan

Site Status

Site JP102

Tokyo, , Japan

Site Status

Site JP107

Tokyo, , Japan

Site Status

Site JP123

Tokyo, , Japan

Site Status

Site KR202

Gyeonggi-do, , South Korea

Site Status

Site KR201

Seoul, , South Korea

Site Status

Site KR203

Seoul, , South Korea

Site Status

Site KR204

Seoul, , South Korea

Site Status

Site TW302

Tainan City, , Taiwan

Site Status

Site TW301

Taipei, , Taiwan

Site Status

Site TW303

Taipei, , Taiwan

Site Status

Countries

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United States Japan South Korea Taiwan

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=262

Link to results on the Astellas Clinical Study Results website

Other Identifiers

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5878-CL-0101

Identifier Type: -

Identifier Source: org_study_id

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