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Farnesyltransferase Inhibitor
Tipifarnib for Cancer
Phase 2
Waitlist Available
Led By Christine A Pratilas
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be >=12 months and =< 21 years of age at the time of study enrollment
Patients must have a body surface area >= 0.29 m^2 at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Study Summary
This trial studies how well tipifarnib works in treating patients with advanced solid tumors, lymphoma, or histiocytic disorders that have a HRAS gene alteration.
Who is the study for?
This trial is for children and young adults up to 21 years old with advanced solid tumors, lymphoma, or histiocytic disorders that have a change in the HRAS gene. They should be able to swallow tablets, have recovered from previous cancer treatments, and meet certain health criteria like blood counts. Pregnant individuals or those on certain medications are excluded.Check my eligibility
What is being tested?
The effectiveness of Tipifarnib is being tested on patients whose cancers have returned or spread and have an HRAS gene alteration. This drug aims to block cancer cell growth linked to this genetic change and potentially shrink tumors.See study design
What are the potential side effects?
While not explicitly listed here, similar drugs can cause side effects such as fatigue, nausea, liver issues, low blood counts leading to infection risk or bleeding problems, rash or other skin changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 21 years old.
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My body surface area is at least 0.29 square meters.
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My nerve-related side effects from previous treatments are mild.
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I am enrolled in APEC1621SC and assigned to APEC1621M due to a specific mutation.
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I have fluid buildup due to cancer.
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I have never been treated with tipifarnib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (complete response + partial response) in pediatric patients treated with tipifarnib
Secondary outcome measures
Percentage of patients experiencing grade 3 or higher adverse events
Progression free survival (PFS)
Other outcome measures
Biomarker analysis
Neoplasms
Side effects data
From undefined Phase 3 trial • 144 Patients • NCT0009347058%
White blood cell decreased
56%
Anemia
54%
Platelet count decreased
35%
Neutrophil count decreased
7%
Fatigue
7%
Rash maculo-papular
6%
Myalgia
3%
Febrile neutropenia
3%
Confusion
1%
Infections and infestations - Other, specify
1%
Catheter related infection
1%
Hypokalemia
1%
Peripheral sensory neuropathy
1%
Eye disorders - Other, specify
1%
Back pain
1%
Treatment related secondary malignancy
1%
Psychosis
1%
Agitation
1%
Acute coronary syndrome
1%
Diarrhea
1%
Nausea
1%
Lung infection
1%
Peripheral nerve infection
1%
Sinusitis
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
GGT increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Tipifarnib)
Arm B (Clinical Observation)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tipifarnib)Experimental Treatment7 Interventions
Patients receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo tumor disease evaluation with PET scan, CT scan, MRI, or MIBG scintigraphy throughout the trial. Patients may undergo bone marrow aspiration or biopsy at baseline, or if there is suspicion of bone marrow metastasis, or when a complete or partial response is identified, or if there is disease progression in the marrow suspected. Patients may undergo blood specimen collections throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Radionuclide Imaging
2004
Completed Phase 2
~50
Tipifarnib
2000
Completed Phase 3
~710
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,104 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,679 Patients Enrolled for Neuroblastoma
Christine A PratilasPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of previous cancer treatments.I am between 12 and 21 years old.You are currently taking other medications for cancer.I have received stem cell infusions and/or radiation therapy within the specified timeframes.I have seizures but they are well controlled with medication.My body surface area is at least 0.29 square meters.My nerve-related side effects from previous treatments are mild.I can swallow pills whole, crushed in liquid, or receive them through a feeding tube.I am enrolled in APEC1621SC and assigned to APEC1621M due to a specific mutation.My cancer can be seen on scans, or if I have neuroblastoma, it shows up on special tests.I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.I can do most activities myself, even if I use a wheelchair.I have an infection that is not responding to treatment.I have fluid buildup due to cancer.You are allergic to imidazoles.You need to have certain levels of blood cells and other substances in your body to be eligible.Your bone marrow is affected by a disease, except if it's been confirmed by a specific scan for neuroblastoma.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.You have had an organ transplant in the past.I have never been treated with tipifarnib.I am not taking medication that strongly affects liver enzymes.You are allergic to tipifarnib or any ingredients in the tablet.Only certain types of scans found specific tumors will be considered, except for neuroblastoma.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tipifarnib)
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.
What is the aggregate quantity of individuals participating in this research project?
"This medical trial requires 49 participants that meet the prescribed requirements. Potential candidates may join from either Nemours Children's Clinic-Jacksonville located in Jacksonville, Florida or Carolinas Medical Center/Levine Cancer Institute situated in Charlotte, North carolina."
Answered by AI
Has Tipifarnib received clearance from the FDA?
"Tipifarnib's safety is rated 2 due to Phase 2 trial data, indicating the presence of some evidence for its security but no proof that it effectively works."
Answered by AI
How many venues are hosting this research endeavor?
"This clinical trial is enrolling patients from the Nemours Children's Clinic in Jacksonville, Florida; Carolinas Medical Center/Levine Cancer Institute located in Charlotte, North carolina; and Duke University Medical Center which resides in Durham, California. Additionally, 100 other medical sites are also participating."
Answered by AI
Are there any vacancies available to participants in this clinical trial?
"Affirmative. Per the clinicaltrials.gov record, this research is currently enlisting volunteer participants; the trial was initially posted on July 13th 2020 and revised as recently as November 1st 2021. This experiment requires 49 individuals to be recruited from 100 sites."
Answered by AI
Do the criteria for this clinical trial coincide with my particular profile?
"This clinical trial seeks to enroll 49 patients with rhabdomyosarcoma, who are between one year old and twenty-one years of age."
Answered by AI
Are there any prior experiments involving Tipifarnib?
"Currently, there are 6 active clinical trials for Tipifarnib. All of these studies are located in Phase 2 and below with Barcelona and Asturias hosting the bulk of them; nevertheless, 520 other sites offer this medication too."
Answered by AI
Does this trial accept participants who are of senior age?
"This research necessitates that potential participants are aged between one year and twenty-one years. According to the database, there are 1186 trials for individuals in this age range and 7813 studies catering to patients over 65."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
University of Nebraska Medical Center
Eastern Maine Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Minnesota
Nebraska
How many prior treatments have patients received?
1
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