Biomarker · Gene alteration

TP53 mutation

Somatic TP53 mutations detected by sequencing of tumor tissue or marrow; used mainly as a prognostic and risk-stratification marker across solid and hematologic malignancies.

CI-BIO-00000034TP53 graph →NCIt C118396

Also calledTP53-mutated · p53 mutation · TP53-mutant

Derived

Associated cancers (26)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Neoplasm	21	21	—	—	0 / 1 / 0 / 19 / 1
Malignant Breast Neoplasm	15	5	10	—	0 / 11 / 1 / 2 / 1
Chronic Lymphocytic Leukemia	7	1	6	—	1 / 6 / 0 / 0 / 0
Malignant Ovarian Neoplasm	7	4	3	—	0 / 5 / 2 / 0 / 0
Gastric Carcinoma

Derived

Drugs with predictive evidence (24)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
MDM2 Inhibitor AMGMDS3	17	1	16	D	1 / 16	Malignant Neoplasm
CisplatinSmall Molecule	9	4	5	B	3 / 5	Gastric Carcinoma, Malignant Gastric Neoplasm,

Curated evidence

Predictive evidence items (52)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 51–52 of 52 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
TP53 Deleterious Mutation1
Pazopanib

Regulatory

Approvals mentioning the linked drugs (444)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

ema

Clinical trials

Active trials (1,111)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 558 recruiting · 287 active phase 3 · 5,094 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 801–850 of 1,111 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03383094	Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer	active not recruiting	Phase 2	126	Loren Mell, MD

Literature

Linked publications (58)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 58 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Clinical impact of clonal and subclonal TP53, SF3B1, BIRC3, NOTCH1, and ATM mutations in chronic lymphocytic leukemia.
· Blood · 2016 · PMID 26837699 · validated civic_curation pubmed
TP53 mutation and survival in chronic lymphocytic leukemia.
· J Clin Oncol · 2010 · PMID 20697090 · validated civic_curation pubmed
Recurrent mutations refine prognosis in chronic lymphocytic leukemia.
· Leukemia · 2015 · PMID 24943832 · validated civic_curation pubmed
Pooled Analysis of the Prognostic and Predictive Effects of TP53 Comutation Status Combined With KRAS or EGFR Mutation in Early-Stage Resected Non-Small-Cell Lung Cancer in Four Trials of Adjuvant Chemotherapy.
· J Clin Oncol · 2017 · PMID 28453411

TP53 H193R + TP53 R175H1

Pazopanib + VorinostatCombination

Sarcoma

Predictive

Supports Sensitivity Response

accepted

EID7540

In the phase I study of pazopanib and vorinostat in 36 patients with advanced solid tumors, detection of hotspot TP53 mutation was associated with a higher rate of SD ≥6 months/PR, longer median PFS (… (full text at CIViC)

PMID 25669829 · Fu et al., 2015 · Open in CIViC

civic

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Docetaxel	EU EMA	—	Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	approved	Nov 27, 1995	ema
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Nov 22, 2022	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Nov 22, 2022	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Nov 22, 2022	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Nov 22, 2022	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration- Resistant Prostate Cancer (CRPC) : with prednisone in metastatic CRPC	approved	Nov 22, 2022	openfda
Docetaxel	US FDA	—	Efficacy supplement 2019-01-08 (see label)	approved	Jan 8, 2019	openfda
Docetaxel	US FDA	—	Efficacy supplement 2014-07-10 (see label)	approved	Jul 10, 2014	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	May 3, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	May 3, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	May 3, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	May 3, 2011	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	May 3, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	—	Efficacy supplement 2010-05-13 (see label)	approved	May 13, 2010	openfda
Docetaxel	US FDA	—	Efficacy supplement 2007-09-28 (see label)	approved	Sep 28, 2007	openfda
Docetaxel	US FDA	—	Efficacy supplement 2006-10-17 (see label)	approved	Oct 17, 2006	openfda
Docetaxel	US FDA	—	Efficacy supplement 2006-03-22 (see label)	approved	Mar 22, 2006	openfda
Docetaxel	US FDA	—	Efficacy supplement 2004-08-18 (see label)	approved	Aug 18, 2004	openfda
Docetaxel	US FDA	—	Efficacy supplement 2004-05-19 (see label)	approved	May 19, 2004	openfda
Docetaxel	US FDA	—	Efficacy supplement 2002-11-27 (see label)	approved	Nov 27, 2002	openfda
Docetaxel	US FDA	—	Efficacy supplement 1999-12-23 (see label)	approved	Dec 23, 1999	openfda
Docetaxel	US FDA	—	Efficacy supplement 1998-06-22 (see label)	approved	Jun 22, 1998	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	May 14, 1996	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	May 14, 1996	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer	approved	May 14, 1996	openfda