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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02937272




Registration number
NCT02937272
Ethics application status
Date submitted
17/10/2016
Date registered
18/10/2016
Date last updated
26/06/2024

Titles & IDs
Public title
A Study of LY3200882 in Participants With Solid Tumors
Scientific title
A Phase 1 Study of LY3200882 in Patients With Solid Tumors
Secondary ID [1] 0 0
I8X-MC-JECA
Secondary ID [2] 0 0
16185
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3200882
Treatment: Drugs - LY3300054
Treatment: Drugs - Gemcitabine
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Cisplatin

Experimental: LY3200882 Schedule 1 Escalation -

Experimental: LY3200882 Schedule 2 Escalation -

Experimental: LY3200882 Schedule 1 Expansion -

Experimental: LY3200882 Schedule 2 Expansion -

Experimental: LY3200882 + LY3300054 -

Experimental: LY3200882 + Gemcitabine + nab-Paclitaxel -

Experimental: LY3200882 + Cisplatin + Radiation -

Experimental: Japanese Arm LY3200882 -


Treatment: Drugs: LY3200882
Administered orally

Treatment: Drugs: LY3300054
Administered intravenously

Treatment: Drugs: Gemcitabine
Administered intravenously

Treatment: Drugs: nab-Paclitaxel
Administered intravenously

Treatment: Drugs: Cisplatin
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Cycle 1 (28 days)
Primary outcome [2] 0 0
Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Timepoint [2] 0 0
Baseline through Disease Progression or Death (estimated at up to 12 months)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882
Timepoint [1] 0 0
Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
Secondary outcome [2] 0 0
PK: AUC Zero to Infinity (AUC[0-8]) at Steady State of LY3200882
Timepoint [2] 0 0
Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
Secondary outcome [3] 0 0
ORR: Percentage of Participants with CR or PR
Timepoint [3] 0 0
Baseline through Disease Progression or Death (estimated at up to 12 months)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months)
Secondary outcome [6] 0 0
Progression-Free Survival (PFS)
Timepoint [6] 0 0
Baseline to Disease Progression or Death (estimated at up to 12 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have moderate or severe cardiovascular disease.
* Have a serious concomitant systemic disorder.
* Have acute leukemia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
223
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 0 0
2298 - Newcastle
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Kowloon
Country [5] 0 0
France
State/province [5] 0 0
Cedex 10
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Villejuif Cedex
Country [8] 0 0
Germany
State/province [8] 0 0
Bayern
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Verona
Country [12] 0 0
Japan
State/province [12] 0 0
Tokyo
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
Spain
State/province [15] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02937272
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02937272