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Anti-metabolites
Nab-paclitaxel for Cancer
Phase 1
Waitlist Available
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be ≥ than 6 months and ≤ 30 years of age at the time of study enrollment
All subjects with relapsed or refractory solid tumors are eligible, excluding primary CNS tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 weeks
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it can effectively treat tumors that haven't responded to other treatments.
Who is the study for?
This trial is for children and young adults aged 6 months to 30 years with solid tumors that haven't responded to standard treatments or have no known effective therapy. Participants must have recovered from previous cancer therapies, meet specific blood count criteria, and not have received certain drugs recently. Pregnant or breastfeeding females are ineligible, as are those unable to follow the study's safety requirements.Check my eligibility
What is being tested?
The study tests nab-paclitaxel in combination with gemcitabine on a weekly basis for three weeks followed by a rest week in a 28-day cycle. It aims to determine the safest high dose without severe side effects, understand side effects and drug handling by the body, check protein levels in tumor tissue for treatment prediction, and assess effectiveness against relapsed/refractory solid tumors.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of the drugs such as nausea and fatigue; blood-related issues like low counts of white cells leading to infection risk; organ inflammation; sensory changes like numbness or tingling due to nerve damage (neuropathy); liver function alterations; and other general discomforts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 months and 30 years old.
Select...
My cancer has returned or didn't respond to treatment, but it's not a brain tumor.
Select...
I can care for myself but may not be able to do active work or play.
Select...
My bone marrow is functioning well.
Select...
My kidney function is within the normal range.
Select...
My liver is working well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum dose tolerated of nab-paclitaxel
Toxicity of nab-paclitaxel
Secondary outcome measures
Antitumor activity of nab-paclitaxel
Blood concentrations of paclitaxel
Change in secreted protein acidic and rich in cysteine (SPARC) expression
Side effects data
From 2016 Phase 3 trial • 50 Patients • NCT0201927770%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Febrile neutropenia
8%
Rash pustular
8%
Lacrimation increased
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Psychotic disorder
2%
Syncope
2%
Gastroenteritis
2%
Dermatitis bullous
2%
Femur fracture
2%
Breast cancer
2%
Device related infection
2%
Wound infection
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gemcitabine + Nab-paclitaxelExperimental Treatment2 Interventions
Participants receiving gemcitabine and nab-paclitaxel for refractory and/or relapsed solid tumors of childhood.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,549 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,212 Total Patients Enrolled
Jonathan Metts, MDStudy ChairJohns Hopkins All Children's Hospital
2 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that are not allowed in the study.I am between 6 months and 30 years old.My cancer has returned or didn't respond to treatment, but it's not a brain tumor.My brain tumor was treated and has been stable for at least 3 months.My doctor thinks standard treatments have a low chance of curing my cancer.I have waited the required time after my last therapy before joining this trial.My bone marrow is functioning well.My kidney function is within the normal range.I can care for myself but may not be able to do active work or play.I have recovered from side effects of my previous cancer treatments.I am not pregnant, breastfeeding, and if of childbearing age, I have a negative pregnancy test and agree to use contraception.My cancer can be measured or seen on tests.My liver is working well.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine + Nab-paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does Nab-paclitaxel present danger for people?
"Nab-paclitaxel is still in Phase 1 trials, meaning that there is limited data to support its safety and efficacy. Our team at Power rates it as a 1 on our safety scale."
Answered by AI
What type of cancer is Nab-paclitaxel most effective against?
"Nab-paclitaxel can be an effective treatment against neoplasm metastasis, locally advanced non-small cell lung cancer, and metastatic bladder cancer."
Answered by AI
Could you please tell us what other researchers have looked into with Nab-paclitaxel?
"There are 1165 active Nab-paclitaxel trials, with the majority being in Phase 3 of research. The drug is being tested at 59852 locations worldwide, but most of the trials are based out of Shanghai, China."
Answered by AI
Who does this research opportunity include?
"This clinical trial has room for 24 total patients that have malignancies and meet the age requirements of being between 6 months to 30 years old."
Answered by AI
How many patients will be given the chance to participate in this research?
"The most recent information available on clinicaltrials.gov suggests that this trial is still actively recruiting patients. The listing for the trial was created on 8/27/2018, and it has been updated as recently as 10/28/2021. They are looking for 24 participants total, across 4 sites."
Answered by AI
Are there any available appointments for this research project?
"Yes, this clinical trial is still open and accepting patients. The listing on clinicaltrials.gov shows that the trial was first posted on 8/27/2018, with the most recent update being 10/28/2021."
Answered by AI
Are patients of majority age eligible for this treatment?
"In order to be included in this clinical trial, patients must aged between 6 months and 30 years old. Out of the 1585 trials for patients over 65, this is one of 117 trials for people under 18."
Answered by AI
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