A Study of LY3200882 in Participants With Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Solid Tumor
• Interventions: Drug: LY3200882; Drug: Cisplatin; Drug: LY3300054; Drug: Gemcitabine; Drug: nab-Paclitaxel; Radiation: Intensity Modulated Radiotherapy

• Registration Number: NCT02937272
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Study Start: 2016-11-21
• Primary Completion: 2020-02-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 223

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3200882 + Gemcitabine + nab-Paclitaxel	nab-Paclitaxel	-
LY3200882 + Cisplatin + Radiation	LY3200882	-
LY3200882 + Cisplatin + Radiation	Cisplatin	-
LY3200882 + Cisplatin + Radiation	Intensity Modulated Radiotherapy	-
Japanese Arm LY3200882	LY3200882	-
LY3200882 Schedule 1 Escalation	LY3200882	-
LY3200882 Schedule 2 Escalation	LY3200882	-
LY3200882 Schedule 1 Expansion	LY3200882	-
LY3200882 Schedule 2 Expansion	LY3200882	-
LY3200882 + LY3300054	LY3200882	-
LY3200882 + LY3300054	LY3300054	-
LY3200882 + Gemcitabine + nab-Paclitaxel	LY3200882	-
LY3200882 + Gemcitabine + nab-Paclitaxel	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	Cycle 1 (28 days)
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 Outcome Measures

Name	Time	Method
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)
PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882	Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
ORR: Percentage of Participants with CR or PR	Baseline through Disease Progression or Death (estimated at up to 12 months)
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)
Overall Survival (OS)	Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Progression-Free Survival (PFS)	Baseline to Disease Progression or Death (estimated at up to 12 months)

Trial Locations

Locations (18)

St Vincent's Hospital Sydney; 🇦🇺 Sydney, New South Wales, Australia

Greenslopes Private Hospital; 🇦🇺 Greenslopes, Queensland, Australia

CHRU de Lille; 🇫🇷 Lille, France

Universitätsklinikum Würzburg A. ö. R.; 🇩🇪 Würzburg, Bayern, Germany

Gustave Roussy; 🇫🇷 Villejuif Cedex, France

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Princess Margaret Hospital (Ontario); 🇨🇦 Lai Chi Kok, Kowloon, Canada

Hopital Saint-Louis; 🇫🇷 Paris, Cedex 10, France

Ospedale Policlinico Giambattista Rossi, Borgo Roma; 🇮🇹 Verona, Italy

National Cancer Center Hospital; 🇯🇵 Chuo-Ku, Tokyo, Japan

Calvary Mater Newcastle; 🇦🇺 Newcastle, New South Wales, Australia

Charité Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States