Study Stopped
Study terminated for meeting protocol specified futility criteria.
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma
3 other identifiers
interventional
23
10 countries
56
Brief Summary
This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2020
Typical duration for phase_1
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedStudy Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2023
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedSeptember 13, 2023
August 1, 2023
3 years
October 29, 2019
August 23, 2023
August 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from randomization until the first investigator-determined objective progression as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause in the absence of progressive disease. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment or date of randomization, whichever is later.
Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)
Secondary Outcomes (6)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Baseline through Measured Progressive Disease (Up To 6.4 Months)
Duration of Response (DoR)
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months)
Complete Response (CR): Percentage of Participants Who Achieve CR
Baseline Up to 6.94 months
Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)
0.5 hours after the end of ramucirumab infusion on Day 1 of Cycle 1
PK: Minimum Serum Concentration of Ramucirumab (Cmin)
Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5
- +1 more secondary outcomes
Study Arms (2)
Ramucirumab + Gemcitabine + Docetaxel
EXPERIMENTALParticipants received intravenous (IV) infusions of ramucirumab 9 milligrams per kilogram (mg/kg), gemcitabine 900 milligrams per meter square (mg/m2) on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
Gemcitabine + Docetaxel
ACTIVE COMPARATORParticipants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose or per the type of previous treatment as stated in the protocol and must have recovered from the acute effects to ≤Grade 2 for alopecia and decreased tendon reflex and to ≤Grade 1 for all other effects at the time of enrollment, unless otherwise noted. Consult with the Lilly clinical research physician or scientist for the appropriate length of time prior to the first dose of study treatment.
- Participants with relapsed, recurrent, or refractory SS.
- Participants must:
- Have measurable disease by Response Evaluation Criteria in Solid Tumors, Version (RECIST) 1.1.
- have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy) that contains ifosfamide and/or doxorubicin, or any approved therapies for which they are eligible, unless the patient is not a suitable candidate for the approved therapy.
- not be eligible for surgical resection at time of enrollment.
- Adequate cardiac function, defined as: Shortening fraction of ≥27% by echocardiogram, or ejection fraction of ≥50% by gated radionuclide study.
- Adequate blood pressure (BP) control, defined as:
- Participants ≥18 years: Controlled hypertension defined as systolic BP ≤150 millimeters of mercury (mmHg) or diastolic BP ≤90 mmHg where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
- Participants \<18 years: A BP ≤95th percentile for age, height, and gender measured as described in National High Blood Pressure Education Program Working Group (NHBPEPWG) on High Blood Pressure in Children and Adolescents (2004), where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
- Adequate hematologic function, as defined as:
- Absolute neutrophil count (ANC): ≥750/microliters (µL) granulocyte-colony stimulating factor (G-CSF) permitted up to 48 hours prior. Participants with documented history of benign ethnic neutropenia or other conditions could be considered with a lower ANC after discussion with and approval from the Lilly clinical research physician or scientist.
- Platelets: ≥75,000/cubic millimeters. Platelet transfusion permitted up to 72 hours prior.
- Hemoglobin: ≥8 grams per deciliter (g/dL) (≥80 g/liter). Transfusions to increase the participant's hemoglobin level to at least 8 g/dL are permitted; however, study treatment must not begin until 7 days after the transfusion, and complete blood count criteria for eligibility are confirmed within 24 hr of first study dose.
- Adequate renal function, as defined as:
- +12 more criteria
You may not qualify if:
- Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
- Participants who have active infections requiring therapy.
- Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
- Participants who have had allogeneic bone marrow or solid organ transplant are excluded.
- Surgery: Participants who have had, or are planning to have, the following invasive procedures are not eligible:
- Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment.
- Central line placement or subcutaneous port placement is not considered major surgery.
- Core biopsy, fine needle aspirate, and bone marrow biopsy/aspirate are not considered major surgeries.
- Surgical or other wounds must be adequately healed prior to enrollment.
- Bleeding and thrombosis:
- Participants with evidence of active bleeding or a history of significant (≥Grade 3) bleeding event within 3 months prior to enrollment are not eligible.
- Participants with a bleeding diathesis or vasculitis are not eligible.
- Participants with known or prior history in the prior 3 months of esophageal varices are not eligible.
- Participants with a history of deep vein thrombosis requiring medical intervention (including pulmonary embolism) within 3 months prior to study enrollment are not eligible.
- Participants with a history of hemoptysis or other signs of pulmonary hemorrhage within 3 months prior to study enrollment are not eligible.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Childrens Hospital of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Childrens Hospital of Los Angeles
Los Angeles, California, 90027, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Childrens Hospital of Orange County
Orange, California, 92868, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202-5225, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
University of Minnesota Hospital
Minneapolis, Minnesota, 55455, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Nationwide Children's Hosp
Columbus, Ohio, 43205-2664, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Cook Children's Hospital
Fort Worth, Texas, 76104-2724, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
The Sydney Children's Hospitals Network
Westmead, New South Wales, 2145, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
UCL- Saint Luc
Brussels, 1200, Belgium
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69008, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076, France
Institut Curie
Paris, 75248, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060, Italy
Azienda Ospedaliera Di Padova
Padua, 35128, Italy
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Leids Universitair Medisch Centrum
Leiden, 2333 ZT, Netherlands
Prinses Maxima Centrum
Utrecht, 3584 CS, Netherlands
Hospital Universitario Virgen Del Rocio
Seville, Andalusia, 41013, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
The Christie
Manchester, Greater Manchester, M20 4BX, United Kingdom
University College Hospital - London
London, NW1 2PG, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Royal Manchester Children's Hospital
Manchester, M139WL, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The limitation to this study was the highly varied estimates of the PFS HR and the probability of PFS HR \< 1 due to influence from the matched historical controls whose PFS substantially outperformed PFS from the prospectively randomized control.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
October 31, 2019
Study Start
March 4, 2020
Primary Completion
February 23, 2023
Study Completion
February 23, 2023
Last Updated
September 13, 2023
Results First Posted
September 13, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.