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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
Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621M based on the presence of an actionable mutation as defined in APEC1621SC
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
No Placebo-Only Group

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 below
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I am enrolled in APEC1621SC and assigned to APEC1621M due to a specific mutation.
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My body surface area is at least 0.29 square meters.
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I have fluid buildup due to cancer.
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I am enrolled in APEC1621SC and assigned to APEC1621M due to a specific mutation.
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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 cancer can be seen on scans, or if I have neuroblastoma, it shows up on special tests.
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I can do most activities myself, even if I use a wheelchair.
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I have recovered from side effects of previous cancer treatments.
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I have received stem cell infusions and/or radiation therapy within the specified timeframes.
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I have never been treated with tipifarnib.
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I have seizures but they are well controlled with medication.
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My nerve-related side effects from previous treatments are mild.
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I can swallow pills whole, crushed in liquid, or receive them through a feeding tube.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

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 • NCT00093470
58%
White blood cell decreased
56%
Anemia
54%
Platelet count decreased
35%
Neutrophil count decreased
7%
Fatigue
7%
Rash maculo-papular
6%
Myalgia
3%
Confusion
3%
Febrile neutropenia
1%
Hypokalemia
1%
Infections and infestations - Other, specify
1%
Catheter related infection
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 1
~1850
Computed Tomography
2017
Completed Phase 2
~2710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Positron Emission Tomography
2008
Completed Phase 2
~2260
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
13,576 Previous Clinical Trials
41,224,140 Total Patients Enrolled
54 Trials studying Wilms Tumor
21,403 Patients Enrolled for Wilms Tumor
Christine A PratilasPrincipal InvestigatorChildren's Oncology Group

Media Library

Tipifarnib (Farnesyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04284774 — Phase 2
Wilms Tumor Research Study Groups: Treatment (tipifarnib)
Wilms Tumor Clinical Trial 2023: Tipifarnib Highlights & Side Effects. Trial Name: NCT04284774 — Phase 2
Tipifarnib (Farnesyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04284774 — Phase 2

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
~25 spots leftby Sep 2027