Farnesyltransferase Inhibitor

Single Group Assignment for Solid Tumors

Gabrail Cancer Center Research, Canton, OH
TipifarnibPhase 1Waitlist AvailableLed by David Sommerhalder, MDResearch Sponsored by Kura Oncology, Inc.

Study Summary

This trial is designed to study the effect of the drug tipifarnib on the heart's electrical activity following a single 900 mg dose and after repeated 600 mg doses given twice a day. The trial will also assess the safety and pharmacokinetics of tipifarnib.

Eligible Conditions
  • Advanced Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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There may be additional requirements you need to meet to be included in the study, which will be explained in the study's specific instructions.
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You have a type of cancer that has spread and there are no other treatments available to you.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ 30 days after treatment discontinuation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after treatment discontinuation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change from baseline in time-matched difference in QTc interval to post-baseline time points after a single 900 mg dose and multiple 600 mg BID doses of tipifarnib in subjects with Advanced Solid Malignancies
Secondary outcome measures
Investigate safety and tolerability of tipifarnib according to NCI CTCAE v5.0

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%
Febrile neutropenia
3%
Confusion
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%
Infections and infestations - Other, specify
1%
Catheter related infection
1%
Lung infection
1%
Peripheral nerve infection
1%
Sinusitis
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
GGT increased
1%
Hypokalemia
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: Single Group AssignmentExperimental Treatment1 Intervention
Single Arm - Drug administered on Days 1-7 and Days 15-21 of a 28-day treatment cycle. Series of Pharmacokinetics and ECGs will be done during cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tipifarnib
Not yet FDA approved

Find a site

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor
12 Previous Clinical Trials
985 Total Patients Enrolled
David Sommerhalder, MDPrincipal Investigator
NEXT Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this treatment undergone the requisite governmental approval processes?

"As this medical trial is in its opening stages, the safety profile of this treatment has only been minimally evaluated and thus receives a score of 1."

Answered by AI

How many individuals have been inducted into this experiment?

"Indeed, clinicaltrials.gov reports that this trial is presently recruiting participants. It was originally posted on May 6th 2021 and last updated on August 19th 2022; the research requires recruitment of 20 patients over 3 different sites."

Answered by AI

Is this investigation still accessible to participants?

"Affirmative, the information on clinicaltrials.gov reveals that this investigation is still recruiting participants. The experiment was initially advertised on May 6th 2021 and its listing was revised as recently as August 19th 2022. In total, 20 individuals are needed from 3 sites for this trial to proceed."

Answered by AI

Has this treatment been tested in any other research studies?

"This treatment made its clinical debut at the Marshfield Medical Center in 2017, with 48 studies done since. Currently, six trials are actively underway - many of them based out of San Antonio, Texas."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies
2021. "Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04865159.
~6 spots leftby Sep 2024
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