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Farnesyltransferase Inhibitor

Single Group Assignment for Solid Tumors

Phase 1

Waitlist Available

Led By David Sommerhalder, MD

Research Sponsored by Kura Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after treatment discontinuation

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after treatment discontinuation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

Fatigue

Rash maculo-papular

Myalgia

Febrile neutropenia

Confusion

Infections and infestations - Other, specify

Catheter related infection

Hypokalemia

Peripheral sensory neuropathy

Eye disorders - Other, specify

Back pain

Treatment related secondary malignancy

Psychosis

Agitation

Acute coronary syndrome

Diarrhea

Nausea

Lung infection

Peripheral nerve infection

Sinusitis

Alanine aminotransferase increased

Aspartate aminotransferase increased

GGT increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm A (Tipifarnib)

Arm B (Clinical Observation)

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor

15 Previous Clinical Trials

1,516 Total Patients Enrolled

David Sommerhalder, MDPrincipal InvestigatorNEXT 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.