Drug · Small Molecule

Pictilisib

CI-DRUG-00000475Explore in graph →NCIt C165479 CHEMBL521851 CIViC Phase 2

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.

Scope	Stage	Max phase	Trials	Jurisdictions	First approval	First trial
All cancers	Phase2	Phase 2	11	—	—	2007-10
Malignant Breast Neoplasm	Phase2	Phase 2	5	—	—	2009-07
Malignant Lung Neoplasm	Phase2	Phase 2	3	—	—	2009-09
Non-Hodgkin Lymphoma	Phase1	Phase 1	1	—

Curated evidence

Clinical evidence (26)

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

civicCuratedShowing 1–26 of 26 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
PIK3CA E545K4
Cisplatin + Pictilisib

Clinical trials

Trials with this intervention (11)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–11 of 11 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
NCT01918306	GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer	terminated	Phase 1 / Phase 2	11	Vanderbilt-Ingram Cancer CenterOTHER	1	Jun 27, 2017	clinicaltrials
NCT01493843	Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

KIT Mutation1
Imatinib + PictilisibCombination	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	2	accepted	EID919 Human GISTs with different KIT mutations were grafted in 136 nude muce. Mice were then treated with control, imatinib, GDC-0941, or GDC-0941 + imatinib. The combination showed superior antitumor effic… (full text at CIViC) PMID 23231951 · Floris et al., 2013 · Open in CIViC	civic

KIT Mutation1

Imatinib + PictilisibCombination

Gastrointestinal Stromal Tumor

Predictive

Supports Sensitivity Response

accepted

EID919

Human GISTs with different KIT mutations were grafted in 136 nude muce. Mice were then treated with control, imatinib, GDC-0941, or GDC-0941 + imatinib. The combination showed superior antitumor effic… (full text at CIViC)

PMID 23231951 · Floris et al., 2013 · Open in CIViC

ERBB2 Amplification2
Pictilisib	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1380 The HER2/Neu mammary tumor mouse model MMTV-NeuT was employed to demonstrate dependence of HER2 tumor formation on PIK3 p110alpha isoform. MMTV-NeuT mice were crossed with floxed p110alpha mice. Diass… (full text at CIViC) PMID 22802530 · Utermark et al., 2012 · Open in CIViC	civic
〃	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID2071 This preclinical study tested the efficacy of GDC-0941, a selective inhibitor of class I PI3K, on several cell lines of breast cancer. Sensitivity and resistance was categorized as less than and more … (full text at CIViC) PMID 20453058 · O'Brien et al., 2010 · Open in CIViC	civic

BRAF V600E2
Azacitidine + PI3K/BET Inhibitor LY294002 + Pictilisib + PLX4720Combination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID13227 Proteomic analysis of BRAFV600E in melanoma and CRC cell lines revealed a greater sensitivity to combination therapy approach with either PI3K and methyltransferase inhibitors along with PLX4720 (Vemu… (full text at CIViC) PMID 23251002 · Mao et al., 2013 · Open in CIViC	civic
Pictilisib	Melanoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID757 One patient with BRAF V600E mutated melanoma (with no detected PI3K pathway deregulation) had a partial response on treatment with pictilisib, a PI3K inhibitor, for 9.5 months. Study was a phase-1 wit… (full text at CIViC) PMID 25370471 · Sarker et al., 2015 · Open in CIViC	civic

PIK3CA Mutation3
Pictilisib	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1616 A panel of 24 endometrioid endometrial cancer (EEC) cell lines was characterized for a set of mutations and sensitivity to pan PI3K class I inhibitor GDC-0941 (pictilisib) was assessed. EEC cell lines… (full text at CIViC) PMID 23674493 · Weigelt et al., 2013 · Open in CIViC	civic
Pictilisib + Tanespimycin + TrametinibSubstitutes	Malignant Head and Neck NeoplasmALIAS	Predictive	D	Does Not Support Sensitivity Response	2	accepted	EID1364 6 head and neck cancer cell lines were tested for Response to 17-AAG, GDC-0941. Two of the cell lines did not carry PIK3CA mutations. No clear difference was shown between PIK3CA-mutant and wild-type … (full text at CIViC) PMID 25855885 · Wirtz et al., 2015 · Open in CIViC	civic
Pictilisib + TanespimycinSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Sensitivity Response	2	accepted	EID1358 Analysis of drug response data from the Sanger center cell line screen. Cell lines with either PI3K and/or PTEN mutations did not show a significant difference in response to class I PI3K inhibitor GD… (full text at CIViC) PMID 25855885 · Wirtz et al., 2015 · Open in CIViC	civic