Tipifarnib

Generic Name: Tipifarnib

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₂₂Cl_₂N_₄O

CAS Number: 192185-72-1

Unique Ingredient Identifier: MAT637500A

Background: Tipifarnib (R-115777) is a substance that is being studied in the treatment of acute myeloid leukemia (AML) and other types of cancer. It belongs to the family of drugs called farnesyltransferase inhibitors. It is also called Zarnestra. In June 2005, the FDA issued a Not Approvable Letter for Zarnestra.

Indication: Investigated for use/treatment in colorectal cancer, leukemia (myeloid), pancreatic cancer, and solid tumors.

Clinical Trials

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Phase 2

Recruiting

Conditions: Neuroblastoma Recurrent

Interventions: Drug: Tipifarnib
Drug: Naxitamab

First Posted Date: 2024-08-07

Last Posted Date: 2025-05-21

Lead Sponsor: Giselle Sholler

Target Recruit Count: 98

Registration Number: NCT06540963

Locations: 🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Randall Children's Hospital, Portland, Oregon, United States
🇺🇸
Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey, Pennsylvania, United States

Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

Phase 1

Withdrawn

Conditions: NSCLC

Interventions: Drug: Tipifarnib
Drug: Osimertinib

First Posted Date: 2023-01-20

Last Posted Date: 2023-03-06

Lead Sponsor: Kura Oncology, Inc.

Registration Number: NCT05693090

Locations: 🇺🇸
The Valley Hospital, Ridgewood, New Jersey, United States
🇺🇸
Providence Medical Group, Santa Rosa, California, United States

Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Phase 1

Active, not recruiting

Conditions: HNSCC

Interventions: Drug: Tipifarnib
Drug: Alpelisib

First Posted Date: 2021-08-10

Last Posted Date: 2025-04-06

Lead Sponsor: Kura Oncology, Inc.

Target Recruit Count: 40

Registration Number: NCT04997902

Locations: 🇺🇸
Lake Nona DDU (Florida Cancer Specialists), Orlando, Florida, United States
🇺🇸
University of Maryland School of Medicine (Marlene and Stewart Greenebaum Comprehensive Cancer Center), Baltimore, Maryland, United States
🇺🇸
Johns Hopkins University School of Medicine (Sidney Kimmel Comprehensive Cancer Center), Baltimore, Maryland, United States

and more 8 locations

Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies

Phase 1

Terminated

Conditions: Advanced Solid Tumor

Interventions: Drug: Tipifarnib

First Posted Date: 2021-04-29

Last Posted Date: 2023-09-21

Lead Sponsor: Kura Oncology, Inc.

Target Recruit Count: 6

Registration Number: NCT04865159

Locations: 🇺🇸
NEXT Oncology, San Antonio, Texas, United States
🇺🇸
Gabrail Cancer Center Research, Canton, Ohio, United States

Expanded Access to Tipifarnib

Conditions: HRAS Mutations or Peripheral T Cell Lymphoma (PTCL)

First Posted Date: 2021-03-22

Last Posted Date: 2024-03-22

Lead Sponsor: Kura Oncology, Inc.

Registration Number: NCT04809233

Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial

Phase 2

Active, not recruiting

Conditions: Malignant Solid Neoplasm
Recurrent Ependymoma
Recurrent Hepatoblastoma
Recurrent Langerhans Cell Histiocytosis
Recurrent Rhabdoid Tumor
Recurrent Rhabdoid Tumor of the Kidney
Recurrent Adrenal Gland Pheochromocytoma
Recurrent Malignant Glioma
Recurrent Non-Hodgkin Lymphoma
Recurrent Osteosarcoma

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Procedure: Radionuclide Imaging
Drug: Tipifarnib

First Posted Date: 2020-02-26

Last Posted Date: 2024-10-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 5

Registration Number: NCT04284774

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States

and more 169 locations

Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

Phase 2

Completed

Conditions: HNSCC
HRAS Gene Mutation

Interventions: Drug: Tipifarnib
Device: HRAS Detection Assay

First Posted Date: 2018-10-25

Last Posted Date: 2024-06-21

Lead Sponsor: Kura Oncology, Inc.

Target Recruit Count: 296

Registration Number: NCT03719690

Locations: 🇺🇸
University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
UCLA - Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

and more 98 locations

Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS

Phase 2

Terminated

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Tipifarnib

First Posted Date: 2018-04-12

Last Posted Date: 2025-03-05

Lead Sponsor: Spanish Lung Cancer Group

Target Recruit Count: 9

Registration Number: NCT03496766

Locations: 🇪🇸
Complejo Hospitalario Universitario de Santiago, Santiago De Compostela, A Coruña, Spain
🇪🇸
Hospital Virgen de los Lirios, Alcoy, Alicante, Spain
🇪🇸
Hospital General Universitario de Elche, Elche, Alicante, Spain

and more 27 locations

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Juvenile Xanthogranuloma
Langerhans Cell Histiocytosis
Malignant Glioma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Ewing Sarcoma
Recurrent Osteosarcoma
Recurrent Primary Central Nervous System Neoplasm
Refractory Hepatoblastoma
Refractory Medulloblastoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Other: Laboratory Biomarker Analysis
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Mutation Carrier Screening
Procedure: Bone Scan
Drug: Larotrectinib Sulfate
Procedure: Computed Tomography
Drug: Olaparib
Drug: Palbociclib
Drug: Tazemetostat
Drug: Samotolisib
Drug: Selumetinib Sulfate
Drug: Ensartinib
Drug: Vemurafenib
Drug: Ulixertinib
Drug: Tipifarnib
Drug: Erdafitinib
Procedure: Magnetic Resonance Imaging
Other: Pharmacological Study
Drug: Selpercatinib
Procedure: Radionuclide Imaging
Procedure: Positron Emission Tomography
Procedure: X-Ray Imaging

First Posted Date: 2017-05-16

Last Posted Date: 2025-05-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1376

Registration Number: NCT03155620

Locations: 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States
🇺🇸
Banner Children's at Desert, Mesa, Arizona, United States

and more 169 locations

Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Leukemia, Myelomonocytic, Chronic

Interventions: Drug: Tipifarnib

First Posted Date: 2016-06-21

Last Posted Date: 2024-07-17

Lead Sponsor: Kura Oncology, Inc.

Target Recruit Count: 44

Registration Number: NCT02807272

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
🇺🇸
Mayo Clinic Florida, Jacksonville, Florida, United States

and more 5 locations

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