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Ramucirumab for Desmoplastic Small Round Cell Tumor

Children Mercy Pediatric Clinical Research Unit, Kansas City, MO
Desmoplastic Small Round Cell TumorRamucirumab - Drug
Eligibility
12 - 29
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Baseline to date of CR (Estimated up to 12 Months)

Month 12
Number of Participants with Anti-Ramucirumab Antibodies
Month 12
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Month 12
Progression Free Survival (PFS)
Month 12
Complete Response (CR): Percentage of Participants Who Achieve CR
Day 28
PK: Minimum Concentration (Cmin)
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Month 12
Duration of Response (DoR)

Trial Safety

Phase-Based Safety

1 of 3

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Side Effects for

Ramucirumab and Docetaxel
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%Constipation
17%Oedema peripheral
16%Pyrexia
16%Mucosal inflammation
14%Febrile neutropenia
14%Vomiting
14%Lacrimation increased
13%Myalgia
13%Leukopenia
12%Peripheral sensory neuropathy
12%Back pain
11%Weight decreased
11%Dysgeusia
11%Hypertension
11%Headache
11%Insomnia
11%Arthralgia
11%Asthenia
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%Dyspepsia
6%Productive cough
6%Haemoptysis
6%Paraesthesia
6%Dysphonia
6%Pneumonia
6%Pain
6%Platelet count decreased
6%Hyperglycaemia
6%Dehydration
5%Bone pain
1%Pneumothorax
1%Atrial fibrillation
1%Lobar pneumonia
1%Chronic obstructive pulmonary disease
1%General physical health deterioration
1%Metastatic pain
1%Death
1%Hyponatraemia
1%Syncope
1%Confusional state
1%Renal failure acute
1%Pleural effusion
1%Pulmonary embolism
1%Pulmonary haemorrhage
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT01168973) in the Ramucirumab and Docetaxel ARM group. Side effects include: Fatigue with 46%, Neutropenia with 36%, Diarrhoea with 32%, Decreased appetite with 30%, Nausea with 27%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2 Treatment Groups

Cyclophosphamide + Vinorelbine
1 of 2
Ramucirumab + Cyclophosphamide + Vinorelbine
1 of 2

Active Control

Experimental Treatment

34 Total Participants · 2 Treatment Groups

Primary Treatment: Ramucirumab · No Placebo Group · Phase 1 & 2

Ramucirumab + Cyclophosphamide + VinorelbineExperimental Group · 3 Interventions: Cyclophosphamide, Vinorelbine, Ramucirumab · Intervention Types: Drug, Drug, Drug
Cyclophosphamide + VinorelbineActiveComparator Group · 2 Interventions: Cyclophosphamide, Vinorelbine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Vinorelbine
FDA approved
Ramucirumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to date of cr (estimated up to 12 months)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,499 Previous Clinical Trials
3,155,321 Total Patients Enrolled
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)Study DirectorEli Lilly and Company
1,280 Previous Clinical Trials
381,771 Total Patients Enrolled

Eligibility Criteria

Age 12 - 29 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have DSRCT that has come back after treatment, or has not responded to previous treatment.
References

Frequently Asked Questions

Are the elderly included in this trial?

"According to the guidelines for who can participate in this research, 12 months is the youngest age allowed and 29 years old is the oldest age limit." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial being conducted at more than one hospital in the state?

"Presently, this study is being conducted in hospitals located in Jacksonville, Fort Myers, Indianapolis and 31 other cities. If you wish to enroll in the trial, try and select a location near to reduce travel time commitments." - Anonymous Online Contributor

Unverified Answer

To whom does this trial cater?

"Eligible patients for this study must have desmoplastic small round cell tumor and be between 12 months to 29 years old. This trial is looking to enroll 34 individuals in total." - Anonymous Online Contributor

Unverified Answer

How many people are chosen to participate in this experiment?

"The data on clinicaltrials.gov does indicate that this study is actively recruiting participants. The trial was first posted on 1/22/2020 and last updated on 9/8/2022. A total of 34 participants are needed for the trial, which will be conducted at 34 different locations." - Anonymous Online Contributor

Unverified Answer

Could you tell me about other research that has been conducted using Ramucirumab?

"Ramucirumab was first studied in 1997 at City of Hope Comprehensive Cancer Center. As of now, 1288 clinical trials have been completed with 955 still active. A majority of these ongoing studies are based in Jacksonville, Florida." - Anonymous Online Contributor

Unverified Answer

What are the most common conditions that doctors use Ramucirumab to treat?

"Ramucirumab is commonly used as an effective treatment for multiple sclerosis, leukemia, myelocytic, acute, and malignant neoplasms." - Anonymous Online Contributor

Unverified Answer

Are people currently being signed up for this clinical trial?

"Yes, as of 9/8/2022 this clinical trial is still recruiting participants, according to the information posted on clinicaltrials.gov. This study was originally advertised on 1/22/2020." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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