Drug · Small Molecule

Regorafenib Anhydrous

CI-DRUG-00000513Explore in graph →NCIt C78204 CHEMBL1946170 CIViC Approved

Regulatory

Approvals (0)

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

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

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.

Data not yet available

No registered interventional trial or approval record places this drug in the pipeline yet.

Curated evidence

Clinical evidence (43)

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

civicCuratedShowing 1–43 of 43 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
KDR R961W1
Regorafenib Anhydrous

Clinical trials

Trials with this intervention (0)

Data not yet available

No registered study lists this drug as an intervention yet.

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase ABL inhibitor; Serine/threonine-protein kinase RAF inhibitor; Stem cell growth factor receptor inhibitor; Fibroblast growth factor receptor 1 inhibitor; MAP kinase p38 beta inhibitor; Fibroblast growth factor receptor 2 inhibitor; Tyrosine-protein kinase FRK inhibitor; Discoidin domain-containing receptor 2 inhibitor; Serine/threonine-protein kinase B-raf inhibitor; Tyrosine-protein kinase TIE-2 inhibitor; Platelet-derived growth factor receptor inhibitor; Vascular endothelial growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor; Ephrin type-A receptor 2 inhibitor; Nerve growth factor receptor Trk-A inhibitor
Targets: 18 genes
Aliases: 4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl)amino)-3-fluorophenoxy)-N-methylpyridine-2-carboxamide, BAY 73 4506, BAY 73-4506, BAY 734506, BAY-734506, BAY 73-4506 monohydrate, BAY-734506 MONOHYDRATE, Regorafenib, Regorafenib Anhydrous, REGORAFENIB ANHYDROUS, Regorafenib hydrate, Regorafenib monohydrate, Stivarga

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (0)

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

Data not yet available

No cross-reference code recorded yet beyond the record identifiers above.

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

BRAF Exon 15 Mutation2
Regorafenib Anhydrous	Gastrointestinal Stromal Tumor	Predictive	C	Does Not Support Sensitivity Response	2	accepted	EID4121 This phase II clinical trial of regorafenib (NCT01068769) examined the long term safety and efficacy of regorafenib monotherapy in patients with metastatic and/or unresectable gastrointestinal stromal… (full text at CIViC) PMID 27371698 · Ben-Ami et al., 2016 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	C	Supports Resistance	1	accepted	EID4605 This retrospective study of a phase 2 clinical trial (NCT01068769) examined regorafenib safety and efficacy in advanced gastrointestinal stromal tumor (GIST) patients refractory to at least imatinib a… (full text at CIViC) PMID 22614970 · George et al., 2012 · Open in CIViC	civic

KIT Exon 11 Mutation3
Regorafenib Anhydrous	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	2	accepted	EID4599 This international, placebo controlled prospective phase 3 clinical trial (NCT01271712) examined safety and efficacy of regorafenib in patients with metastatic and/or unresectable gastrointestinal str… (full text at CIViC) PMID 23177515 · Demetri et al., 2013 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	2	accepted	EID4629 This retrospective study of a phase 2 clinical trial (NCT01068769) examined regorafenib safety and efficacy in advanced gastrointestinal stromal tumor (GIST) patients who failed previous treatments wi… (full text at CIViC) PMID 22614970 · George et al., 2012 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	3	accepted	EID6377 This phase II clinical trial of regorafenib (NCT01068769) examined the long term safety and efficacy of regorafenib in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIS… (full text at CIViC) PMID 27371698 · Ben-Ami et al., 2016 · Open in CIViC	civic

KIT Exon 9 Mutation3
Regorafenib Anhydrous	Gastrointestinal Stromal Tumor	Predictive	B	Supports Reduced Sensitivity	2	accepted	EID4139 This retrospective study of a phase 2 clinical trial (NCT01068769) examined regorafenib safety and efficacy in advanced gastrointestinal stromal tumor (GIST) patients who failed previous treatments wi… (full text at CIViC) PMID 22614970 · George et al., 2012 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	2	accepted	EID4628 This international, placebo controlled prospective phase 3 clinical trial (NCT01271712) examined safety and efficacy of regorafenib in patients with metastatic and/or unresectable gastrointestinal str… (full text at CIViC) PMID 23177515 · Demetri et al., 2013 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	C	Supports Reduced Sensitivity	3	accepted	EID4104 This phase II clinical trial of regorafenib (NCT01068769) examined the long term safety and efficacy of regorafenib monotherapy in patients with metastatic and/or unresectable gastrointestinal stromal… (full text at CIViC) PMID 27371698 · Ben-Ami et al., 2016 · Open in CIViC	civic

KIT K642E2
Regorafenib Anhydrous	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	—	submitted	EID4146 In an in vitro study, a GIST 882 cell line expressing KIT K642E mutation demonstrated increased sensitivity to regorafenib treatment (IC50: 45 nM vs. 560-3269nM) compared to HepG2, SW620, Colo-205 or … (full text at CIViC) PMID 21170960 · Wilhelm et al., 2011 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	D	Does Not Support Sensitivity Response	3	rejected	EID7398 A cell line derived from GIST882 patients expressing KIT K642E mutation demonstrated insensitivity to regorafenib (IC50: 503nmol/L) treatment. IC50 was determined by assessing cell viability. PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic

KRAS G12A2
Regorafenib Anhydrous	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID3716 In a phase 1 clinical trial (NCT01187615) of advanced, chemotherapy-naive, lung adenocarcinoma patients (n=9), a patient with KRAS G12A mutation was reported to have partial response (progression free… (full text at CIViC) PMID 26003007 · Hellmann et al., 2015 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID3710 In an in vitro study, a human colon adenocarcinoma SW48 cell line virally transduced to express KRAS G12A demonstrated resistance to regorafenib treatment (IC50: 330.13 nM vs. 114.28 nM, P<0.01, repor… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic

KRAS G12V2
Regorafenib Anhydrous	Malignant Colon Neoplasm	Predictive	D	Supports Sensitivity Response	—	submitted	EID3932 In an in vitro study, a SW480 cell line expressing KRAS G12V mutation was associated with sensitivity to regorafenib treatment, as compared to Caco-2 and KM12SM cells expressing wild-type KRAS. Resist… (full text at CIViC) PMID 26865419 · Takigawa et al., 2016 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID3924 In an in vitro study, a human colon adenocarcinoma SW48 cell line expressing KRAS G12V mutation demonstrated resistance to regorafenib treatment (IC50: 241.90 nM vs. 114.28 nM, P<0.01) compared to SW4… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic