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Synovial SarcomaPhase 1/2NCT04145700

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma

A Phase 1/2 study testing Ramucirumab, Gemcitabine and Docetaxel in people with Synovial Sarcoma, run by Eli Lilly and Company at 56 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 months to 29 years
Conditions the study is for
Synovial Sarcoma
What is being tested?
Ramucirumab, Gemcitabine and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
56 sitesin 10 countries
Study dates
4 Mar 2020to 23 Feb 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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:
  • Creatinine clearance or radioscope glomerular filtration rate (GFR) ≥60 milliliters/minute/meters squared OR serum creatinine meeting the following parameters:
  • for participants ≥18 years of age serum creatinine ≤1.5×upper limit of normal (ULN);
  • for participants <18 years of age, serum creatinine based on age/gender as follows: Age 1 to <2 years maximum serum creatinine 0.6, Age 2 to <6 years maximum serum creatinine 0.8, Age 6 to <10 years maximum serum creatinine 1.0, Age 10 to <13 years maximum serum creatinine 1.2, Age 13 to <16 years maximum serum creatinine 1.5 for males and 1.4 for females, Age 16 to <18 years maximum serum creatinine 1.7 for males and 1.4 for females.
  • Urine protein meeting the following parameters:
  • for participants ≥18 years of age: <2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study.
  • for participants <18 years of age: ≤30 milligrams per deciliter urine analysis or <2+ on dipstick. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <1 g of protein in 24 hours to allow participation in the study.
  • Adequate liver function:
  • Total bilirubin: ≤1.5×ULN. Except participants with document history of Gilbert Syndrome who must have a total bilirubin level of <3.0×ULN.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): ≤2.5×ULN OR ≤5.0×ULN if the liver has tumor involvement.
  • The participant has an adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5×ULN, and partial thromboplastin time ≤1.5×ULN if not receiving anticoagulation therapy. For participants receiving anticoagulants, exceptions to these coagulation parameters are allowed if they are within the intended or expected range for their therapeutic use. Participants must have no history of clinically significant active bleeding (defined as within 14 days of first dose of study drug) or pathological condition that carries a high risk of bleeding (for example, tumor involving major vessels or known esophageal varices).
  • The participant has adequate hematologic and organ function ≤1 week (7 days) prior to first dose of study drug.
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to randomization. Male and female participants must agree to use highly effective contraception for the duration of the study and up to 3 months following the last dose of ramucirumab and 6 months following the last dose of docetaxel and gemcitabine in order to prevent pregnancy.

Who cannot join

  • 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.
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  • 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.
  • Cardiac:
  • Participants with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to study enrollment are not eligible.
  • Participants with myocardial infarction or unstable angina within the prior 6 months.
  • Participants with New York Heart Association Grade 2 or greater congestive heart failure (CHF).
  • Participants with serious and inadequately controlled cardiac arrhythmia.
  • Participants with significant vascular disease (eg, aortic aneurysm, history of aortic dissection).
  • Participants with clinically significant peripheral vascular disease.
  • Participants who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrollment are not eligible.
  • Participants with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible.
  • Participants who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment are not eligible.
  • Participants previously treated and progressed on combination gemcitabine and docetaxel regimen. Participants who received combination as maintenance therapy, without progression, would be eligible.
  • Participants with a known hypersensitivity to ramucirumab, gemcitabine, docetaxel, or agents formulated with Polysorbate 80.
  • Hepatic impairment:
  • Severe liver cirrhosis Child-Pugh Class B (or worse).
  • Cirrhosis with a history of hepatic encephalopathy.
  • Clinically meaningful ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
  • History of hepatorenal syndrome.
  • The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (eg, hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
  • The participant has symptomatic interstitial pneumonia or pulmonary fibrosis (or consistent findings of interstitial pneumonia/pulmonary fibrosis on imaging).
  • Participants with central nervous system (CNS) involvement are ineligible.

Trial locations and contacts

56 sites in 10 countries.

56 sites in 10 countries

United States27 sites

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045

  • Childrens Hospital of Alabama

    Birmingham, Alabama, 35233

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Nationwide Children's Hosp

    Columbus, Ohio, 43205-2664

  • Children's Medical Center Dallas

    Dallas, Texas, 75235

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Hospital

    Fort Worth, Texas, 76104-2724

  • Texas Children's Hospital

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202-5225

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Childrens Hospital of Los Angeles

    Los Angeles, California, 90027

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Hospital

    Minneapolis, Minnesota, 55455

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Childrens Hospital of Orange County

    Orange, California, 92868

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Seattle Children's Hospital Research Foundation

    Seattle, Washington, 98105

  • Washington University Medical School

    St Louis, Missouri, 63110

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Spain5 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna

  • Hospital Universitario Virgen Del Rocio

    Seville, Andalusia, 41013

Other trials in Spain

Australia4 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • The Sydney Children's Hospitals Network

    Westmead, New South Wales, 2145

Other trials in Australia

Italy4 sites

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060

  • Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • Azienda Ospedaliera Di Padova

    Padova, 35128

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom4 sites

  • University College Hospital - London

    London, NW1 2PG

  • Royal Marsden Hospital

    London, SW3 6JJ

  • The Christie

    Manchester, Greater Manchester, M20 4BX

  • Royal Manchester Children's Hospital

    Manchester, M139WL

Other trials in United Kingdom

France3 sites

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33076

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Institut Curie

    Paris, 75248

Other trials in France

Germany3 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

Belgium2 sites

  • UCL- Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

Japan2 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Kyushu University Hospital

    Fukuoka, 812-8582

Other trials in Japan

Netherlands2 sites

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZT

  • Prinses Maxima Centrum

    Utrecht, 3584 CS

Other trials in Netherlands

About this study

Official title: A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma

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.

Being tested
Ramucirumab, Gemcitabine, Docetaxel
Keywords
soft tissue sarcoma, adolescents and young adults (AYAs), adolescent
Medical subject headings
Sarcoma, Synovial, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamucirumabDrug

    Also called LY3009806

    Ramucirumab given IV

  • GemcitabineDrug

    Gemcitabine given IV

  • DocetaxelDrug

    Docetaxel given IV

Study groups in NCT04145700
Study groupRoleWhat they receive
Ramucirumab + Gemcitabine + DocetaxelExperimentalParticipants 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.
Receives: Drug: Ramucirumab; Drug: Gemcitabine; Drug: Docetaxel
Gemcitabine + DocetaxelActive 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.
Receives: Drug: Gemcitabine; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)

Secondary outcomes (6)

  1. Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

    ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

    Measured: Baseline through Measured Progressive Disease (Up To 6.4 Months)

  2. Duration of Response (DoR)

    DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence.

    Measured: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months)

  3. Complete Response (CR): Percentage of Participants Who Achieve CR

    CR is a disappearance of all target and non-target lesions and normalization of tumor marker level.

    Measured: Baseline Up to 6.94 months

  4. Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)

    Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics.

    Measured: 0.5 hours after the end of ramucirumab infusion on Day 1 of Cycle 1

  5. PK: Minimum Serum Concentration of Ramucirumab (Cmin)

    Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics.

    Measured: Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5

  6. Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)

    A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer >= 20 (treatment-induced).

    Measured: Baseline Up to 6.94 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study start4 Mar 2020
  3. Primary completion23 Feb 2023
  4. Study completion23 Feb 2023

Why it stopped: Study terminated for meeting protocol specified futility criteria.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145700
Sponsor's protocol ID
17306
Other IDs
J1S-MC-JV02, 2018-004243-23, 2018
Status last verified
Aug 2023
First submitted
29 Oct 2019
Last updated
13 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ramucirumab, Gemcitabine and Docetaxel in people with Synovial Sarcoma, run by Eli Lilly and Company at 56 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Spain, Australia, Italy, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04145700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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