A Study of LY3200882 in Participants With Solid Tumors

Solid Tumor Clinical Trial

Official title:

A Phase 1 Study of LY3200882 in Patients With Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02937272
• Other study ID #: 16185
• Secondary ID: I8X-MC-JECA2016-
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 21, 2016
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 223
• Est. completion date: August 1, 2024
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• LY3200882
Administered orally
• LY3300054
Administered intravenously
• Gemcitabine
Administered intravenously
• nab-Paclitaxel
Administered intravenously
• Cisplatin
Administered intravenously

Radiation:
• Intensity Modulated Radiotherapy

Locations

Country	Name	City	State
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	St Vincent's Hospital Sydney	Sydney	New South Wales
Canada	Princess Margaret Hospital (Ontario)	Lai Chi Kok	Kowloon
France	CHRU de Lille	Lille
France	Hopital Saint-Louis	Paris	Cedex 10
France	Gustave Roussy	Villejuif Cedex
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Universitätsklinikum Würzburg A. ö. R.	Würzburg	Bayern
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Ospedale Policlinico Giambattista Rossi, Borgo Roma	Verona
Japan	National Cancer Center Hospital	Chuo-Ku	Tokyo
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Clínico Universitario de Valencia	Valencia
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)		Cycle 1 (28 days)
Primary	Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)		Baseline through Disease Progression or Death (estimated at up to 12 months)
Secondary	Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882		Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
Secondary	PK: AUC Zero to Infinity (AUC[0-8]) at Steady State of LY3200882		Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
Secondary	ORR: Percentage of Participants with CR or PR		Baseline through Disease Progression or Death (estimated at up to 12 months)
Secondary	Overall Survival (OS)		Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Secondary	Duration of Response (DoR)		Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months)
Secondary	Progression-Free Survival (PFS)		Baseline to Disease Progression or Death (estimated at up to 12 months)

External Links

•   Click here for more information about this study: A Study of LY3200882 in Participants With Solid Tumors