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A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

NCT02860780

Description:

The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.

Related Conditions:
  • Cancer
  • Colon Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title:A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer
  • Official Title:A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: 16379
  • SECONDARY ID: I4D-MC-JTJL
  • SECONDARY ID: 2015-005611-33
  • NCT ID: NCT02860780

Trial Conditions

  • Advanced Cancer
  • Metastatic Cancer
  • Colorectal Cancer
  • Non-small Cell Lung Cancer

Trial Interventions

DrugSynonymsArms
prexasertibLY2606368Part A: prexasertib + ralimetinib
ralimetinibLY2228820Part A: prexasertib + ralimetinib

Trial Purpose

The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Part A: prexasertib + ralimetinibExperimentalPrexasertib given intravenously (IV) and ralimetinib given orally.
  • prexasertib
  • ralimetinib
Part B1: prexasertib + ralimetinib (colorectal cancer)ExperimentalPrexasertib given IV and ralimetinib given orally.
  • prexasertib
  • ralimetinib
Part B2: prexasertib + ralimetinib (NSCLC)ExperimentalPrexasertib given IV and ralimetinib given orally.
  • prexasertib
  • ralimetinib

Eligibility Criteria

Inclusion Criteria:

- Advanced or metastatic cancer.

- Able to swallow tablets.

- For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations.

- Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy.

Exclusion Criteria:

- Active infection (fungal, viral, or bacterial).

- Active cancer in your brain or spinal cord.

- Acute or chronic leukemia.

- Serious heart condition.

- Disease that requires immunosuppressant therapy.

- Diagnosis of inflammatory bowel disease.

- Major small bowel resection that interferes with your body's ability to absorb the oral medicine.

- Participated in other clinical trials investigating prexasertib or ralimetinib.

- Pregnant or breastfeeding.

- Other pre-existing conditions or medical history which your doctor will explain to you.

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
Time Frame:Cycle 1 (28 Days)
Safety Issue:No
Description:

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
Time Frame:Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:No
Description:
Measure:PK: Area Under the Curve (AUC) of Prexasertib
Time Frame:Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:No
Description:
Measure:PK: Cmax of Ralimetinib
Time Frame:Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:No
Description:
Measure:PK: AUC of Ralimetinib
Time Frame:Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:No
Description:
Measure:Best Overall Response (BOR): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE)
Time Frame:Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Estimated up to 32 Weeks)
Safety Issue:No
Description:
Measure:Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)
Safety Issue:No
Description:
Measure:Duration of Response (DOR)
Time Frame:Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 32 Weeks)
Safety Issue:No
Description:
Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)
Safety Issue:No
Description:

Trial Keywords