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Trial record 1 of 1 for:    NCT02937272
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A Study of LY3200882 in Participants With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02937272
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: LY3200882 Drug: LY3300054 Drug: Gemcitabine Drug: nab-Paclitaxel Drug: Cisplatin Radiation: Intensity Modulated Radiotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 223 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3200882 in Patients With Solid Tumors
Actual Study Start Date : November 21, 2016
Estimated Primary Completion Date : June 7, 2019
Estimated Study Completion Date : May 3, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3200882 Schedule 1 Escalation Drug: LY3200882
Administered orally

Experimental: LY3200882 Schedule 2 Escalation Drug: LY3200882
Administered orally

Experimental: LY3200882 Schedule 1 Expansion Drug: LY3200882
Administered orally

Experimental: LY3200882 Schedule 2 Expansion Drug: LY3200882
Administered orally

Experimental: LY3200882 + LY3300054 Drug: LY3200882
Administered orally

Drug: LY3300054
Administered intravenously

Experimental: LY3200882 + Gemcitabine + nab-Paclitaxel Drug: LY3200882
Administered orally

Drug: Gemcitabine
Administered intravenously

Drug: nab-Paclitaxel
Administered intravenously

Experimental: LY3200882 + Cisplatin + Radiation Drug: LY3200882
Administered orally

Drug: Cisplatin
Administered intravenously

Radiation: Intensity Modulated Radiotherapy
Experimental: Japanese Arm LY3200882 Drug: LY3200882
Administered orally




Primary Outcome Measures :
  1. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]
  2. Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) ]
  2. PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) ]
  3. ORR: Percentage of Participants with CR or PR [ Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months) ]
  4. Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 12 months) ]
  5. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months ]
  6. Progression-Free Survival (PFS) [ Time Frame: Baseline to Disease Progression or Death (estimated at up to 12 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937272


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact    415-514-6568      
Principal Investigator: Pamela Munster         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact    502-562-4158      
Principal Investigator: Rebecca Redman         
United States, New York
NYU Clinical Cancer Center Not yet recruiting
New York, New York, United States, 10016
Contact    212-263-2441      
Principal Investigator: Dimitris Placantonakis         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact    646-962-6137      
Principal Investigator: Howard Fine         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-563-5844      
Principal Investigator: Timothy Yap         
Australia, New South Wales
Calvary Mater Newcastle Recruiting
Newcastle, New South Wales, Australia, 2298
Contact    61243401581      
Principal Investigator: Andre van der Westhuizen         
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact    6193555655      
Principal Investigator: Anthony Joshua         
Australia, Queensland
Greenslopes Private Hospital Recruiting
Greenslopes, Queensland, Australia, 4120
Contact    61733947111      
Principal Investigator: Victoria Atkinson         
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact    4169462277      
Principal Investigator: Warren P Mason         
France
Hopital Saint-Louis Recruiting
Paris, Cedex 10, France, 75475
Contact    33171207466      
Principal Investigator: Antoine Carpentier         
CHRU de Lille- Hôpital Roger Salengro Recruiting
Lille, France, 59037
Contact    33662688717      
Principal Investigator: Emilie Le Rhun         
Hôpital Saint Joseph Recruiting
Paris, France, 75014
Contact    330144127456      
Principal Investigator: ERIC RAYMOND         
Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Contact    33142114338      
Principal Investigator: Christophe Massard         
Germany
Universitätsklinikum Würzburg Recruiting
Würzburg, Bayern, Germany, 97080
Contact    4993120140160      
Principal Investigator: Mario Löhr         
Universitätsklinikum Essen Recruiting
Essen, Nordrhein-Westfalen, Germany, 45122
Contact    492017232024      
Principal Investigator: Jörg Hense         
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 12203
Contact    493084452648      
Principal Investigator: Sebastian Ochsenreither         
Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact    390282244080      
Principal Investigator: Matteo Simonelli         
Ospedale Policlinico Giambattista Rossi, Borgo Roma Recruiting
Verona, Italy, 37134
Contact    390458128148      
Principal Investigator: Davide Melisi         
Japan
National Cancer Center Hospital Not yet recruiting
Chuo-Ku, Tokyo, Japan, 104-0045
Contact    81120360605      
Principal Investigator: Shunsuke Kondo         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact    34934894374      
Principal Investigator: Elena Garralda Cabanas         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact    34913908000      
Principal Investigator: Juan Manuel Sepúlveda Sánchez         
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact    34961973528      
Principal Investigator: Andres Cervantes Ruiperez         
Switzerland
Ospedale Regionale di Bellinzona e Valli - Bellinzona Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact    41918118931      
Principal Investigator: Anastasios Stathis         
Universitätsspital Zürich Recruiting
Zürich, Switzerland, 8091
Contact    41442552214      
Principal Investigator: Christian Britschgi         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02937272     History of Changes
Other Study ID Numbers: 16185
I8X-MC-JECA ( Other Identifier: Eli Lilly and Company )
2016-001431-12 ( EudraCT Number )
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 1, 2019

Keywords provided by Eli Lilly and Company:
TGF Beta

Additional relevant MeSH terms:
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Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs