Therapy Detail

Therapy Name Taselisib
Therapy Description

Taselisib (GDC-0032) is a beta isoform-sparing PI3K inhibitor, with greater activity against oncogenic mutants of PIK3CA (PMID: 23662903).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Taselisib RG7606|GDC-0032 PIK3CA inhibitor 14 PIK3CD inhibitor 24 PIK3CG inhibitor 8 Taselisib (GDC-0032) is a beta isoform-sparing PI3K inhibitor, with greater activity against oncogenic mutants of PIK3CA (PMID: 23662903).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PTEN mutant head and neck squamous cell carcinoma resistant Taselisib Preclinical - Cell line xenograft Actionable In a preclinical study, head and neck squamous cell carcinoma cell lines and cell line xenograft models with PTEN alterations were resistant to the apoptotic effects of Taselisib (GDC-0032) (PMID: 26589432). 26589432
PTEN del head and neck squamous cell carcinoma resistant Taselisib Preclinical Actionable In a preclinical study, head and neck squamous cell carcinoma cells homozygous for PTEN deletion were resistant to Taselisib (GDC-0032) in culture (PMID: 26589432). 26589432
Unknown unknown Advanced Solid Tumor not applicable Taselisib Phase I Actionable In a Phase I trial, Taselisib (GDC-0032) demonstrated safety and preliminary efficacy in patients with advanced solid tumors (Cancer Res Feb 2016 (76) (4 Supplement) P3-14-10). detail...
ERBB2 amp uterine corpus serous adenocarcinoma sensitive Taselisib Preclinical - Cell culture Actionable In a preclinical study, a uterine serous carcinoma cell line harboring ERBB2 (HER2) amplification demonstrated sensitivity to treatment with Taselisib (GDC-0032) in culture, resulting in inhibition of cell growth (PMID: 26333383). 26333383
Clinical Trial Phase Therapies Title Recruitment Status
NCT02465060 Phase II Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT02340221 Phase III Fulvestrant Taselisib SANDPIPER Study: A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy Active, not recruiting
NCT02273973 Phase II Taselisib Study of Neoadjuvant Letrozole + GDC-0032 Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI) Completed
NCT02390427 Phase I Trastuzumab Paclitaxel Pertuzumab Taselisib Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer Recruiting
NCT01296555 Phase I Fulvestrant Taselisib Letrozole A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors And in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer Active, not recruiting
NCT02457910 Phase Ib/II Enzalutamide Taselisib Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer Active, not recruiting
NCT02154490 Phase II Docetaxel Palbociclib Durvalumab AZD4547 Taselisib Erlotinib AMG102 Lung-MAP: S1400 Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IIIB-IV Squamous Cell Lung Cancer Recruiting
NCT02785913 Phase II Taselisib Lung-MAP: Taselisib as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches Active, not recruiting