Trial · NCT04284774
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
NCT04284774, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial. Trials, record NCT04284774. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04284774
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
- NCT number
- NCT04284774
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma, Recurrent Ectomesenchymoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Melanoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdoid Tumor of the Kidney, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Thyroid Gland Carcinoma, Recurrent WHO Grade 2 Glioma, Refractory Adrenal Gland Pheochromocytoma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Melanoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdoid Tumor of the Kidney, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory Thyroid Gland Carcinoma, Refractory WHO Grade 2 Glioma
- Interventions
- Tipifarnib
- First posted
- 2020-02-26
- Last updated
- 2026-10-16
- Results first posted
- 2025-06-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib | Up to 2 years from study entry | A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors. |
| Secondary | Progression Free Survival (PFS) | Up to 6 months from study entry | The Kaplan-Meier method will be used to estimate the 6-month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact |
| Secondary | Percentage of Patients Experiencing Grade 3 or Higher Adverse Events | Up to 2 years from study entry | Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 |
| Other | Biomarker Analysis | Up to 7 years | Will evaluate other biomarkers as predictors of response to tipifarnib and whether tumors that harbor different missense mutations or fusions will demonstrate differential response to treatment. |
| Other | Profiling Changes in Tumor Genomics | Baseline, prior to cycle 5, end of treatment, assessed up to 7 years | Will explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib | Up to 2 years from study entry | percentage of patients | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | Up to 6 months from study entry | |||
| SECONDARY | Percentage of Patients Experiencing Grade 3 or Higher Adverse Events | Up to 2 years from study entry | |||
| OTHER_PRE_SPECIFIED | Biomarker Analysis | Up to 7 years | |||
| OTHER_PRE_SPECIFIED | Profiling Changes in Tumor Genomics | Baseline, prior to cycle 5, end of treatment, assessed up to 7 years |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib | Treatment (Tipifarnib) | 0 | 90% Confidence Interval 0 to 0 | percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Tipifarnib) | 5 | |
| Overall Study | COMPLETED | Treatment (Tipifarnib) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Tipifarnib) | 5 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Tipifarnib) | 3 | 5 | |
| other | Abdominal distension | Gastrointestinal disorders | Treatment (Tipifarnib) | 1 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Tipifarnib) | 1 | 5 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Tipifarnib) | 1 | 5 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Tipifarnib) | 1 | 5 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Tipifarnib) | 1 | 5 | |
| other | Vomiting | Gastrointestinal disorders | Treatment (Tipifarnib) | 2 | 5 | |
| other | Disease progression | General disorders | Treatment (Tipifarnib) | 1 | 5 | |
| other | Edema limbs | General disorders | Treatment (Tipifarnib) | 1 | 5 | |
| other | Fatigue | General disorders | Treatment (Tipifarnib) | 1 | 5 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Tipifarnib) | 4 | 5 |
| Total, other adverse events | Treatment (Tipifarnib) | 3 | 5 |
| Total, serious adverse events | Treatment (Tipifarnib) | 2 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42853672 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04284774
GET https://conductscience.org/api/trials/v1/NCT04284774/events?page=2