Drug · Small Molecule

Docetaxel

CI-DRUG-00000190Explore in graph →NCIt C1526 CHEMBL3545252 CIViC Approved

Regulatory

Approvals (75)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory9 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Breast cancer Taxespira 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. Taxespira 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. Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Taxespira 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 Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Taxespira 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 Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxespira 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 Taxespira 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.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 15 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	314	160	436	1,701	75	CA, EU, US	Nov 27, 1995	1993-05
Malignant Lung Neoplasm	Approved	Phase 4	79	36	117	401	8	US	May 14, 1996	1996-12
Malignant Breast Neoplasm	Approved	Phase 4	51	27	107	353	8	US	May 14, 1996	1993-05
Malignant Prostate Neoplasm	Approved	Phase 3	41	22	47	222

Curated evidence

Clinical evidence (29)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–29 of 29 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
KRAS Amplification1
Carboplatin + Docetaxel

Clinical trials

Trials with this intervention (1,729)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1,651–1,700 of 1,729 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
NCT00268671	Docetaxel in Squamous Cell Carcinoma of the Head and Neck (TAX + Cisplatin in SCCHN)	completed	Phase 1 / Phase 2	45	SanofiINDUSTRY	0	Dec 7, 2009	clinicaltrials
NCT00268710	Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]	completed	Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Tubulin inhibitor; Tubulin stabiliser
Targets: 15 genes
UNII: 699121PHCA
Aliases: [2aR-[2a Alphaa,4beta,4a Beta,6beta,9alpha,(alphaR*,betaS*),-11alpha,12alpha,12a Alpha,12b Alpha]]-beta-[[(1,1-dimethylethoxy)carbonyl]-amino]-alpha-hydroxybenzemepropanoic Acid 12b-(Acetyloxy)-12(benzyloxy)-2a,3,4,4a,5,6,8,10,11,12,12a,12b-dodecahydeo-4,-6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl Ester, ACT DOCETAXEL 40 MG/ML, BEIZRAY, Docecad, Docefrez, Docetaxel, Docetaxel accord, DOCETAXEL ANHYDROUS, Docetaxel (as trihydrate), Docetaxel hydrate, Docetaxel Kabi, Docetaxel Mylan, Docetaxel teva, Docetaxel Teva Pharma, Docetaxel trihydrate, Docetaxel Zentiva, Docetaxel zentiva (previously docetaxel winthrop), DOCIVYX, N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol, PMS-DOCETAXEL, RP 56976, RP56976, TARO-DOCETAXEL, Taxceus, Taxespira, Taxespira (previously docetaxel hospira uk limited ), Taxotere, Taxotere Injection Concentrate, XRP6976

Data updated 18 hours agoSource updated unknown

Identifiers

Codes (40)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01CD02

ERBB2 Amplification2
Docetaxel + Pertuzumab + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	5	accepted	EID1077 CLEOPATRA (NCT00567190) was a Phase III, randomized and double-blind, placebo-controlled study of 808 patients with HER2-positive metastatic breast cancer. Patients were HER2-positive by IHC3+ or FIS… (full text at CIViC) PMID 25693012 · Swain et al., 2015 · Open in CIViC	civic
〃	HER2-Positive Breast CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID1437 In a randomized phase 3 trial, HER2 positive metastatic breast cancer patients given first-line treatment of pertuzumab plus trastuzumb plus docetaxel experienced improved progression free survival (1… (full text at CIViC) PMID 22149875 · Baselga et al., 2012 · Open in CIViC	civic

KRAS Mutation5
Docetaxel	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	4	accepted	EID4997 Of the 275 patients assessable for KRAS mutation status, 49 (18%) were positive for KRAS mutation. There were no differences between treatments in OS, PFS, or response rates according to KRAS mutation… (full text at CIViC) PMID 20038723 · Douillard et al., 2010 · Open in CIViC	civic
Docetaxel + ErlotinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	4	accepted	EID4996 222 EGFR-wt patients with advanced NSCLC were randomized to receive docetaxel or erlotinib In this study (4 patients not eligible, leaving 109 in each arm). KRAS was mutated in 25 and 26 out of 109 pa… (full text at CIViC) PMID 26209642 · Rulli et al., 2015 · Open in CIViC	civic
Docetaxel + SelumetinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Resistance	5	accepted	EID2998 A phase 3 study of selumetinib and docetaxel in KRAS mutant, previously treated NSCLC. 866 were enrolled and 510 randomized. Median progression-free survival was 3.9 months with selumetinib + docetaxe… (full text at CIViC) PMID 28492898 · Jänne et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID999 87 patients with KRAS mutant stage IIB-IV NSCLC after first line therapy were randomly assigned (1:1) to oral selumetunib and docetaxel or docetaxel and Placebo. Median OS was 9·4 months (6·8-13·6) in… (full text at CIViC) PMID 23200175 · Jänne et al., 2013 · Open in CIViC	civic
Docetaxel + Pemetrexed + TrametinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4862 This phase I/Ib two-part study evaluated trametinib in combination with anticancer agents docetaxel or pemetrexed in NSCLC with and without KRAS mutations. Confirmed partial response (PR) was observed… (full text at CIViC) PMID 27876675 · Gandara et al., 2017 · Open in CIViC	civic

YAP1 Overexpression2
Docetaxel + FluorouracilSubstitutes	Malignant Esophageal Neoplasm	Predictive	D	Supports Resistance	2	submitted	EID1982 YAP1 up-regulation of EGFR plays an important role in conferring therapy resistance to 5-FU or docetaxel in esophageal cancer (EC) cells. Inhibitor of YAP1, Verteporfin, can overcome the acquired chem… (full text at CIViC) PMID 25739674 · Song et al., 2015 · Open in CIViC	civic
Docetaxel + VerteporfinCombination	Malignant Esophageal Neoplasm	Predictive	D	Supports Sensitivity Response	2	submitted	EID9329 YAP1 and EGFR were found to be highly expressed in esophageal cancer (EC) cells and play an important role in resistance to 5-FU or docetaxel. Treatment of the EC cell line JHESO with the YAP1 inhibit… (full text at CIViC) PMID 25739674 · Song et al., 2015 · Open in CIViC	civic

PTEN Loss2
Capivasertib + DocetaxelCombination	Malignant Gastric Neoplasm	Predictive	D	Supports Sensitivity Response	1	accepted	EID1500 A patient derived mouse xenograft model was established with gastric cancer cells having PTEN loss. The xenograft was resistant to monotherapy with both the pan-Akt inhibitor AZD5363, and also to the … (full text at CIViC) PMID 24088382 · Li et al., 2013 · Open in CIViC	civic
Docetaxel	Malignant Gastric Neoplasm	Predictive	D	Supports Resistance	2	accepted	EID11064 SGC020 was a gastric PDGCX mouse model established from a gastric cancer patient, with a PTEN exon 2-6 gene deletion resulting in undetectable PTEN protein expression. The chemotherapy Taxotere was gi… (full text at CIViC) PMID 24088382 · Li et al., 2013 · Open in CIViC	civic