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CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

Primary Purpose

Desmoplastic Small Round Cell Tumor

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ramucirumab
Cyclophosphamide
Vinorelbine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Desmoplastic Small Round Cell Tumor focused on measuring soft tissue sarcoma, adolescents and young adults (AYAs), adolescent

Eligibility Criteria

12 Months - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 DSRCT.
  • 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). This prior treatment must include approved therapies for which they are eligible, unless the participant 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:

    • 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 vinorelbine, and 12 months following the last dose of cyclophosphamide in order to prevent pregnancy.

Exclusion Criteria:

  • 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.
  • 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 cyclophosphamide and vinorelbine regimen. Participants who received combination as maintenance therapy, without progression, would be eligible.
  • Participants with a known hypersensitivity to ramucirumab, cyclophosphamide, vinorelbine or any of the excipients of the medicinal products.
  • 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 a urinary outflow obstruction.
  • The participant has Grade 2 hematuria or non-infectious cystitis at the time of screening.
  • Participants with central nervous system (CNS) involvement are ineligible.

Sites / Locations

  • Phoenix Children's Hospital
  • Childrens Hospital of Los Angeles
  • Children's Hospital Colorado
  • Children's National Medical Center
  • Lee Health- Golisano Children's hosptial of southwest Florida
  • Children's Healthcare of Atlanta - Egleston Hospital
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Riley Hospital for Children at Indiana University Health
  • C.S. Mott Children's Hospital
  • Children's Mercy Hospital
  • Washington University
  • Oregon Health and Science University
  • Children's Hospital of Philadelphia (CHOP)
  • UPMC Hillman Cancer Center
  • Children's Health
  • Cook Children's Medical Center
  • Seattle Children's Hospital
  • Chris O'Brien Lifehouse
  • The Children's Hospital at Westmead
  • Royal Children's Hospital
  • Cliniques universitaires Saint-Luc
  • Institut Curie
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
  • National Cancer Center Hospital
  • Kyushu University Hospital
  • Leids Universitair Medisch Centrum
  • Princess Máxima Center for Pediatric Oncology
  • Hospital de la Santa Creu i Sant Pau
  • University College London Hospital
  • Royal Marsden Hospital (Sutton)
  • Royal Manchester Children's Hospital
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ramucirumab + Cyclophosphamide + Vinorelbine

Cyclophosphamide + Vinorelbine

Arm Description

Ramucirumab given intravenously (IV), Cyclophosphamide given orally and vinorelbine given IV.

Cyclophosphamide given orally and vinorelbine given IV.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
PFS

Secondary Outcome Measures

Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR
Duration of Response (DoR)
DoR
Complete Response (CR): Percentage of Participants Who Achieve CR
CR
Pharmacokinetics (PK): Maximum Concentration (Cmax)
PK: Cmax
PK: Minimum Concentration (Cmin)
PK: Cmin
Number of Participants with Anti-Ramucirumab Antibodies
Number of Participants with Anti-Ramucirumab Antibodies

Full Information

First Posted
October 29, 2019
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04145349
Brief Title
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor
Official Title
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 desmoplastic small round cell tumor (DSRCT) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Desmoplastic Small Round Cell Tumor
Keywords
soft tissue sarcoma, adolescents and young adults (AYAs), adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ramucirumab + Cyclophosphamide + Vinorelbine
Arm Type
Experimental
Arm Description
Ramucirumab given intravenously (IV), Cyclophosphamide given orally and vinorelbine given IV.
Arm Title
Cyclophosphamide + Vinorelbine
Arm Type
Active Comparator
Arm Description
Cyclophosphamide given orally and vinorelbine given IV.
Intervention Type
Drug
Intervention Name(s)
Ramucirumab
Other Intervention Name(s)
LY3009806
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS
Time Frame
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Description
ORR
Time Frame
Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Title
Duration of Response (DoR)
Description
DoR
Time Frame
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 12 Months)
Title
Complete Response (CR): Percentage of Participants Who Achieve CR
Description
CR
Time Frame
Baseline to date of CR (Estimated up to 12 Months)
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Description
PK: Cmax
Time Frame
Cycle 1 through Cycle 10 (28 Day Cycles)
Title
PK: Minimum Concentration (Cmin)
Description
PK: Cmin
Time Frame
Cycle 1 through Cycle 10 (28 Day Cycles)
Title
Number of Participants with Anti-Ramucirumab Antibodies
Description
Number of Participants with Anti-Ramucirumab Antibodies
Time Frame
Baseline through End of Study (Estimated up to 12 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 DSRCT. 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). This prior treatment must include approved therapies for which they are eligible, unless the participant 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: 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 vinorelbine, and 12 months following the last dose of cyclophosphamide in order to prevent pregnancy. Exclusion Criteria: 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. 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 cyclophosphamide and vinorelbine regimen. Participants who received combination as maintenance therapy, without progression, would be eligible. Participants with a known hypersensitivity to ramucirumab, cyclophosphamide, vinorelbine or any of the excipients of the medicinal products. 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 a urinary outflow obstruction. The participant has Grade 2 hematuria or non-infectious cystitis at the time of screening. Participants with central nervous system (CNS) involvement are ineligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Childrens Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Lee Health- Golisano Children's hosptial of southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Children's Healthcare of Atlanta - Egleston Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Riley Hospital for Children at Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Children's Hospital of Philadelphia (CHOP)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Bruxelles-Capitale, Région De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Princess Máxima Center for Pediatric Oncology
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08041
Country
Spain
Facility Name
University College London Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton)
City
London
State/Province
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/2xgNRPjTAJn4VfcQ6hkfrA
Description
CAMFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

Learn more about this trial

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

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