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NCT Number: NCT02937272

A Study of LY3200882 in Participants With Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Solid Tumor Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Calvary Mater Newcastle, Newcastle, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3200882

Drug

Administered orally

LY3300054

Drug

Administered intravenously

Gemcitabine

Drug

Administered intravenously

Nab-paclitaxel

Drug

Administered intravenously

Cisplatin

Drug

Administered intravenously

Intensity modulated radiotherapy

Radiation

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1 Study of LY3200882 in Patients With Solid Tumors

Important dates

Study start
2016
Primary completion
2020
Study completion
2027
First posted
Oct 18, 2016
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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