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Anti-metabolites

Ramucirumab for 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

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
  • Synovial Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6.94 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6.94 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
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 more

Side effects data

From 2016 Phase 3 trial • 1253 Patients • NCT01168973
46%
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%
Insomnia
11%
Arthralgia
11%
Hypertension
11%
Asthenia
11%
Dysgeusia
11%
Headache
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Nail discolouration
7%
Rash
7%
Dizziness
6%
Dehydration
6%
Hyperglycaemia
6%
Dysphonia
6%
Haemoptysis
6%
Productive cough
6%
Dyspepsia
6%
Paraesthesia
6%
Pain
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Lobar pneumonia
1%
Metastatic pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
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

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
~5620

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,800 Total Patients Enrolled
1 Trials studying Synovial Sarcoma
113 Patients Enrolled for Synovial Sarcoma
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
418,246 Total Patients Enrolled
~4 spots leftby Sep 2025
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