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

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Status and phase

Completed
Phase 1

Conditions

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

Treatments

Drug: prexasertib
Drug: ralimetinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02860780
I4D-MC-JTJL (Other Identifier)
2015-005611-33 (EudraCT Number)
16379

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

9 participants in 2 patient groups

Part A: prexasertib + ralimetinib
Experimental group
Description:
Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally. Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally.
Treatment:
Drug: ralimetinib
Drug: prexasertib
Part B1: prexasertib + ralimetinib (colorectal cancer)
Experimental group
Description:
60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle.
Treatment:
Drug: ralimetinib
Drug: prexasertib

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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