Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Tipifarnib

Tipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles

HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

HRAS Detection Assay

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

KO-TIP-007 is an international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN) and the impact of HRAS mutations on response to first line systemic therapies for HNSCC (SEQ-HN). KO-TIP-007 has 2 study cohorts. The first study cohort, named AIM-HN, includes HNSCC subjects with HRAS mutations. AIM-HN subjects will receive treatment with tipifarnib and the outcome of this cohort will be evaluated for ORR by an independent review facility.

The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

HNSCC patients in whom HRAS mutations are identified and who meet eligibility criteria will be offered participation in AIM-HN. HNSCC patients in whom HRAS mutations are not identified may participate in SEQ-HN only. These patients will be followed and the comparison of outcomes of HRAS mutant and HRAS wild type HNSCC will address the exploratory objective to determine the effect of HRAS mutation on the ORR of first line systemic therapy in patients with recurrent/metastatic HNSCC. Outcome data from subsequent lines of therapy will be collected.

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

A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) With HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)

Determine anti-tumor activity of tipifarnib

Incidence of adverse events, incidence of abnormal laboratory test results, abnormal vital signs, and abnormal ECG results

Measured by changes of quality of life using the EORTC QLQ-H\&N35

Measured by blood samples collected during the first 6 cycles of treatment

Measured by changes of quality of life using the EQ-5D-5L.

Kura Oncology, Inc.

Digestive System Diseases

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Thyroid Diseases

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Esophageal Cancer

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Bile Duct Cancer

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Small Intestine Cancer

Neuroepithelioma

Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor

Ulixertinib (BVD-523)

xCures Clinical Operations

Louis B Nabors, MD

Marshall Schreeder, MD

Jose Galeas, MD

David Palchak, MD

Richard M Green, MD

Michael Demeure, MD

Naveed Wagle, MD

Benjamin A Weinberg, MD

Jennifer E. Tseng, MD

Joshua Lukenbill, DO

Jon Olson, MD

Philip L. Brooks, MD

Mohammad Mobayed, MD

Nathan B. Green, DO

Seth Cohen, MD

Carl J. Minniti Jr., MD

Bonni Guerin, MD

MInsig Choi, MD

Manish Bhandari, MD

Rex Mowat, MD

Suresh Nair, MD

Elena G Chiorean, MD

The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.

Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.

Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies

Cancer Commons

xCures

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy	NCT03719690	HRAS Gene Mutat... HNSCC	Tipifarnib HRAS Detection ...	18 Years -	Kura Oncology, Inc.
Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies	NCT04566393	Pancreatic Canc... Small Bowel Can... Colorectal Canc... Melanoma Non Small Cell ... Thyroid Cancer Bladder Cancer Head and Neck C... Gastric Cancer Esophageal Canc... Cholangiocarcin... Ovarian Cancer Hepatocellular ... Glioblastoma MAPK Gene Mutat... KRAS Activating... BRAF Gene Mutat... NRAS Gene Mutat... HRAS Gene Mutat... MEK Mutation ERK Mutation	Ulixertinib (BV...	12 Years -	xCures
Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy	NCT03719690	HRAS Gene Mutat... HNSCC	Tipifarnib HRAS Detection ...	18 Years -	Kura Oncology, Inc.

Spots Global Cancer Trial Database for hras gene mutation