Clinical trial NCT02937272: A Study of LY3200882 in Participants With Solid Tumors
Official title: A Phase 1 Study of LY3200882 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Keywords: TGF Beta
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.


Eligibility criteria: Inclusion Criteria:

* The participant must have histological or cytological evidence of cancer.
* Have adequate organ function.
* Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.
* Are able to swallow capsules and tablets.

Exclusion Criteria:

* Have moderate or severe cardiovascular disease.
* Have a serious concomitant systemic disorder.
* Have acute leukemia.

Primary outcomes:
measure: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
timeFrame: Cycle 1 (28 days)
measure: Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Disease Progression or Death (estimated at up to 12 months)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
measure: PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
measure: ORR: Percentage of Participants with CR or PR
timeFrame: Baseline through Disease Progression or Death (estimated at up to 12 months)
measure: Overall Survival (OS)
timeFrame: Baseline to Date of Death from Any Cause (estimated at up to 12 months)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months)
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to Disease Progression or Death (estimated at up to 12 months)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Lai Chi Kok
country: Canada
facility: Princess Margaret Hospital (Ontario)
state: Kowloon
city: Paris
country: France
facility: Hopital Saint-Louis
state: Cedex 10
city: Lille
country: France
facility: CHRU de Lille
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg A. ö. R.
state: Bayern
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Verona
country: Italy
facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Yap TA, Vieito M, Baldini C, Sepulveda-Sanchez JM, Kondo S, Simonelli M, Cosman R, van der Westhuizen A, Atkinson V, Carpentier AF, Lohr M, Redman R, Mason W, Cervantes A, Le Rhun E, Ochsenreither S, Warren L, Zhao Y, Callies S, Estrem ST, Man M, Gandhi L, Avsar E, Melisi D. First-In-Human Phase I Study of a Next-Generation, Oral, TGFbeta Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer. Clin Cancer Res. 2021 Dec 15;27(24):6666-6676. doi: 10.1158/1078-0432.CCR-21-1504. Epub 2021 Sep 21.