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A Study of LY3200882 in Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02937272
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : December 3, 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 9, 2016
Estimated Primary Completion Date : July 29, 2020
Estimated Study Completion Date : December 30, 2020

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) ]


Information from the National Library of Medicine

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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
Show Show 20 study locations
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    
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: December 3, 2019
Last Verified: December 2019
Keywords provided by Eli Lilly and Company:
TGF Beta
Additional relevant MeSH terms:
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Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
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