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Anti-metabolites
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6.94 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment in children and young adults with synovial sarcoma. Participation could last up to 12 months.
Eligible Conditions
- Soft tissue cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 6.94 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6.94 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Complete Response (CR): Percentage of Participants Who Achieve CR
Duration of Response (DoR)
Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)
+3 moreSide effects data
From 2016 Phase 3 trial • 1253 Patients • NCT0116897346%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Back pain
12%
Peripheral sensory neuropathy
11%
Hypertension
11%
Insomnia
11%
Asthenia
11%
Arthralgia
11%
Dysgeusia
11%
Headache
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Pain in extremity
8%
Oropharyngeal pain
8%
Thrombocytopenia
7%
Dizziness
7%
Nail discolouration
7%
Rash
6%
Hyperglycaemia
6%
Dehydration
6%
Dysphonia
6%
Pain
6%
Dyspepsia
6%
Paraesthesia
6%
Haemoptysis
6%
Productive cough
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Lobar pneumonia
1%
Hyponatraemia
1%
Metastatic pain
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ramucirumab + Gemcitabine + DocetaxelExperimental Treatment3 Interventions
Participants 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.
Group II: Gemcitabine + DocetaxelActive Control2 Interventions
Participants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Gemcitabine
2017
Completed Phase 3
~1920
Docetaxel
1995
Completed Phase 4
~6550
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,361 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,818 Total Patients Enrolled