A Study of LY3200882 in Participants With Solid Tumors

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Solid Tumor

Treatments: Drug: LY3200882; Drug: Cisplatin; Radiation: Intensity Modulated Radiotherapy; Drug: Gemcitabine; Drug: nab-Paclitaxel; Drug: LY3300054

Study type: Interventional

Funder types: Industry

Identifiers

NCT02937272

16185

2016-001431-12 (EudraCT Number)

I8X-MC-JECA (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 223 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 8 patient groups

LY3200882 Schedule 1 Escalation

Experimental group

Treatment:

Drug: LY3200882

LY3200882 Schedule 2 Escalation

Experimental group

Treatment:

Drug: LY3200882

LY3200882 Schedule 1 Expansion

Experimental group

Treatment:

Drug: LY3200882

LY3200882 Schedule 2 Expansion

Experimental group

Treatment:

Drug: LY3200882

LY3200882 + LY3300054

Experimental group

Treatment:

Drug: LY3300054

Drug: LY3200882

LY3200882 + Gemcitabine + nab-Paclitaxel

Experimental group

Treatment:

Drug: nab-Paclitaxel

Drug: Gemcitabine

Drug: LY3200882

LY3200882 + Cisplatin + Radiation

Experimental group

Treatment:

Radiation: Intensity Modulated Radiotherapy

Drug: Cisplatin

Drug: LY3200882

Japanese Arm LY3200882

Experimental group

Treatment:

Drug: LY3200882