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Alkylating agents

Ramucirumab for Desmoplastic Small Round Cell Tumor

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
Participants must not be eligible for surgical resection at the time of enrollment.
Participants with relapsed, recurrent, or refractory DSRCT.
Must not have
Participants with a history of thromboembolic events, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia, significant vascular disease, peripheral vascular disease, fistula, gastrointestinal ulcer or perforation, intra-abdominal abscess, hypertensive crisis, non-healing wounds, unhealed fractures, compound bone fractures, or hypersensitivity to study drugs.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of cr (estimated up to 12 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment in children and young adults with DSRCT that has come back or continued after other treatments.

Who is the study for?
This trial is for children and young adults with relapsed, recurrent, or refractory Desmoplastic Small Round Cell Tumor (DSRCT). Participants must have tried at least one systemic treatment before, not be eligible for surgery, and have adequate organ function. They should not have severe infections, recent significant bleeding events or thrombosis, uncontrolled hypertension, certain heart conditions or a history of severe liver disease.
What is being tested?
The study tests the safety and effectiveness of Ramucirumab combined with chemotherapy drugs Cyclophosphamide and Vinorelbine in treating DSRCT. It's part of a larger protocol aiming to speed up new cancer treatments for young patients. The commitment could exceed 12 months based on individual response to treatment.
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills; damage to blood cells leading to increased infection risk; hair loss; nausea; fatigue; potential bleeding issues due to Ramucirumab affecting blood vessels; and possible harm to organs like the heart or liver from the medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I cannot have surgery for my condition right now.
Select...
My DSRCT cancer has come back or hasn't responded to treatment.
Select...
I stopped my previous cancer treatments at least 7 days ago and have recovered from their side effects.
Select...
My blood pressure is within the normal range for my age.
Select...
My heart is strong, with a good pumping ability.
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My liver functions are within the required range for the study.
Select...
My kidney function is good, based on tests.
Select...
My blood clotting tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of serious heart, blood vessel problems, or severe reactions to medications.
Select...
I do not have any active severe infections like HIV or hepatitis.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I am currently being treated for an active infection.
Select...
I do not have severe liver problems or certain serious digestive or urinary conditions.
Select...
I have not had major surgery, significant injuries, or a central line placed in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of cr (estimated up to 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of cr (estimated up to 12 months) for reporting.

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 Anti-Ramucirumab Antibodies
+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%
Headache
11%
Arthralgia
11%
Dysgeusia
11%
Hypertension
11%
Insomnia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Nail discolouration
7%
Dizziness
6%
Haemoptysis
6%
Pain
6%
Hyperglycaemia
6%
Dyspepsia
6%
Dehydration
6%
Dysphonia
6%
Paraesthesia
6%
Productive cough
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Lobar pneumonia
1%
Metastatic pain
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 + Cyclophosphamide + VinorelbineExperimental Treatment3 Interventions
Ramucirumab given intravenously (IV), Cyclophosphamide given orally and vinorelbine given IV.
Group II: Cyclophosphamide + VinorelbineActive Control2 Interventions
Cyclophosphamide given orally and vinorelbine given IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Cyclophosphamide
2010
Completed Phase 4
~2310
Vinorelbine
2013
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,678 Previous Clinical Trials
3,465,661 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
428,134 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04145349 — Phase 1 & 2
Desmoplastic Small Round Cell Tumor Research Study Groups: Ramucirumab + Cyclophosphamide + Vinorelbine, Cyclophosphamide + Vinorelbine
Desmoplastic Small Round Cell Tumor Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04145349 — Phase 1 & 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04145349 — Phase 1 & 2
~6 spots leftby Dec 2025
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