Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02937272