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OpenTrials
Completed

NCT Number: NCT02860780

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

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.

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Key information

Conditions

Advanced Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Non-small Cell Lung Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Prexasertib

Drug

Administered IV

Other names: LY2606368

ralimetinib

Drug

Administered orally

Other names: LY2228820

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib

    Time frame: Cycle 1 (28 Days)

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib

    Time frame: Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)

  2. PK: Area Under the Curve (AUC) of Prexasertib

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  3. PK: Cmax of Ralimetinib

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  4. PK: AUC of Ralimetinib

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  5. 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)

  6. 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)

  7. 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)

  8. Progression Free Survival (PFS)

    Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Dec 14, 2018

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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