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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
No Placebo-Only Group

Summary

This trial tests tipifarnib on cancer patients with advanced tumors to see its effect on the heart's electrical activity, specifically the time it takes for the heart to recharge between beats. Tipifarnib has been tested in various cancer types, including advanced solid tumors and breast cancer.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
Confusion
3%
Febrile neutropenia
1%
Catheter related infection
1%
Infections and infestations - Other, specify
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)

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 Location

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor
18 Previous Clinical Trials
1,728 Total Patients Enrolled
David Sommerhalder, MDPrincipal InvestigatorNEXT Oncology
~1 spots leftby Nov 2025
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