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Trial record 6 of 6 for:    LY3009806 hepatocellular

A Study of LY2875358 in Combination With Ramucirumab (LY3009806) in Participants With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT02082210
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to find a recommended schedule and dose range for LY2875358 when given with ramucirumab that may be safely given to participants with cancer. In Part A of this study, escalating doses of LY2875358 will be given in combination with a fixed dose of ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose range of LY2875358 and ramucirumab has been established, Part B of the study will confirm safety and to see how well certain tumors respond to the combination of study drugs. The average amount of time on study is expected to be about 6 months.

Condition or disease Intervention/treatment Phase
Advanced Cancer Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Hepatocellular Cancer Renal Cell Carcinoma Non-Small Cell Lung Cancer Drug: LY2875358 Drug: Ramucirumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of Ramucirumab in Combination With LY2875358 in Patients With Advanced Cancer
Actual Study Start Date : March 7, 2014
Actual Primary Completion Date : December 5, 2017
Actual Study Completion Date : January 24, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab

Arm Intervention/treatment
Experimental: LY2875358 + Ramucirumab (Part A)
Part A: Dose escalation of LY2875358 administered intravenously (IV), on days 1 and 15 every 28 day cycle in combination with a fixed dose of ramucirumab administered IV on Days 1 and 15 every 28 day cycle.
Drug: LY2875358
Administered Intravenously (IV)

Drug: Ramucirumab
Administered Intravenously (IV)
Other Names:
  • LY3009806
  • IMC-1121B

Experimental: LY2875358 + Ramucirumab (Part B)
Part B: Recommended LY2875358 dose from Part A to be administered IV, on days 1 and 15 every 28 day cycle in combination with a fixed dose of ramucirumab administered IV on Days 1 and 15 every 28 day cycle.
Drug: LY2875358
Administered Intravenously (IV)

Drug: Ramucirumab
Administered Intravenously (IV)
Other Names:
  • LY3009806
  • IMC-1121B




Primary Outcome Measures :
  1. Part A: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 day cycle) ]
  2. Part B: Proportion of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] [ Time Frame: Baseline through Measured Progressive Disease or Death (Estimated up to 2 years) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2875358 [ Time Frame: Cycle 1 Day 1 to Day 15 (28 day cycle) ]
  2. Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)] [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 2 years) ]
  3. Progression Free Survival (PFS) [ Time Frame: Baseline to Measured Progressive Disease or Death (Estimated up to 2 years) ]
  4. Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2875358 [ Time Frame: Cycle 1 Day 1 to Day 15 (28 day cycle) ]
  5. Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab [ Time Frame: Cycle 1 Day 1 to Day 15 (28 day cycle) ]
  6. Number of Participants with Anti-Ramucirumab and Anti-LY2875358 Antibodies [ Time Frame: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 2 years) ]
  7. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ramucirumab [ Time Frame: Cycle 1 Day 1 to Day 15 (28 day cycle) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histological or cytological confirmed diagnosis of the following tumor types that is advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate participant for experimental therapy

    • Part A: Any type of solid tumor ("all comer")
    • Part B1: Gastric or Gastroesophageal Junction (GEJ) adenocarcinoma
    • Part B2: Hepatocellular cancer (excluding fibrolamellar carcinoma)
    • Part B3: Renal cell carcinoma (any histology)
    • Part B4: Non-small cell lung cancer (squamous or non-squamous)
  • Have at least 1 measurable lesion outside of the central nervous system (CNS) whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Availability of a tumor sample taken after progression on the most recent line of systemic tumor therapy or willing to undergo a tumor biopsy pre-study treatment.
  • Have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale in Part A and ≤ 1 on the ECOG scale in Part B.
  • Have adequate organ function.
  • Routine urinalysis showing ≤1+ protein or protein/creatinine ratio <0.5. For proteinuria ≥2+ or urine protein/creatinine ratio ≥0.5, 24-hour urine must be collected and the level must be <1 gram of protein in 24 hours for subject enrollment.
  • Have discontinued all previous cancer therapies and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 halflives prior to study enrollment, whichever is shorter, and recovered from the acute effects for therapy.
  • Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete 8 weeks (2 cycles) of treatment.
  • Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for at least 3 months following the last dose of study drug. Females with childbearing potential must have had a negative serum pregnancy test 7 days before the first dose of study drug and must not be breast-feeding.

Exclusion Criteria:

  • Have serious pre-existing medical conditions (at the discretion of the investigator, such as severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation).
  • Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
  • Participant has experienced any arterial thromboembolic event (ATE), including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, within 6 months prior to receiving study drugs.
  • Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolic event during the 3 months prior to receiving study drugs.
  • Are receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents. Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that they are on low-molecular weight heparin or oral factor Xa inhibitors.
  • The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs or other antiplatelet agents. Aspirin use at doses up to 325 mg/day is permitted.
  • Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to receiving study drugs.
  • Have a history of GI perforation and/or fistulae within 6 months prior to receiving study drugs.
  • Have congestive heart failure (CHF) New York Heart Association class ≥3 or symptomatic or poorly controlled cardiac arrhythmia.
  • Have undergone major surgery within 28 days prior to receiving study drugs.
  • Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to receiving study drugs.
  • Have a known active fungal, bacterial, and/or known viral infection. Hepatocellular cancer participants with chronic viral (B or C) hepatitis are eligible if they retain adequate liver function.
  • Have liver cirrhosis with a Child-Pugh Stage of B or C.
  • Have symptomatic CNS malignancy (with the exception of medulloblastoma) or metastasis.
  • Have corrected QT (QTc) interval of >470 milliseconds on screening electrocardiogram (ECG).
  • Have received previous treatment with ramucirumab or LY2875358, except for participants enrolled in cohort B1 (Gastric or GEJ adenocarcinoma) and B4 (non- small cell lung cancer) who may have received previous ramucirumab treatment.
  • Known hypersensitivity to any of the treatment components of ramucirumab or LY2875358.
  • Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
  • Are pregnant or breastfeeding.
  • For Part B4 (non-small cell lung cancer) only:

    • The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer
    • Participants with a history of gross hemoptysis within 2 months prior to study treatment
    • The participant has radiographic evidence of intratumor cavitation, regardless of tumor histology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082210


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-3117
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02082210     History of Changes
Other Study ID Numbers: 15246
I4C-MC-JTBF ( Other Identifier: Eli Lilly and Company )
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carcinoma, Renal Cell
Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Liver Diseases