Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatocellular Carcinoma Melanoma Non Small Cell Lung Cancer Renal Cell Carcinoma Urothelial Cancer

Keywords

checkpoint inhibitor naiveMetastaticPD-L1

Outcome Measures

Primary Outcomes (1)

Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), confirmed by ≥1 repeat assessment ≥28 days later, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to 733 days

Secondary Outcomes (4)

Disease Control Rate (DCR)
up to 733 days

Study Arms (1)

INCB086550

EXPERIMENTAL

INCB086550 will be administered orally twice a day.

Drug: INCB086550

Interventions

INCB086550Drug

INCB086550 will be administered orally twice a day.

INCB086550

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Ability to comprehend and willingness to sign a written ICF for the study.
Participants with following tumor types : non small cell lung cancer, renal cell carcinoma, urothelial carcinoma, hepatocellular carcinoma and melanoma

Sponsors & Collaborators

Incyte Corporation
Industrylead

Study Sites (20)

Complex Oncology Center - Burgas Eood

Burgas, 8000, Bulgaria

Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" Jsc

Gabrovo, 5300, Bulgaria

Complex Onclogy Center Plovdiv Eood

Plovdiv, 4004, Bulgaria

Shatod Dr. Marko - Varna Ltd

Varna, 9000, Bulgaria

Semmelweis Egyetem

Budapest, 1085, Hungary

Complex Oncology Center - Burgas Eood

Farkasgyepű, 8582, Hungary

Bacs Kiskun Megyei Oktatokorhaz

Kecskemét, 6000, Hungary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellCarcinoma, HepatocellularMelanomaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinoma

Limitations and Caveats

Enrollment in this study was discontinued after INCB086550 program development was terminated by the sponsor due to business reasons.

Results Point of Contact

Title: Study Director
Organization: Incyte Corporation

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 16, 2020

Study Start

September 2, 2021

Actual (reported)

Study Stopped

Study of INCB086550 in Select Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

INCB086550

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Study Stopped

Study of INCB086550 in Select Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

INCB086550

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations