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NCT04729387

III

Platinum resistant or refractory gBRCA WT high grade serous or endometrioid ovarian cancer

EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

AZ, AR, FL, IL, MD, MA, NY, OH, SD, TN, TX

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Drug(s) in Trial	Other Drug Names	Main Known Action	Drug Status
Alpelisib	PI3K inhibitor BYL719, BYL719, phosphoinositide 3-Kinase inhibitor BYL719, Piqray	PI3K alpha inhibitor	Approved in Other Cancers
Olaparib	AZD2281, Lynparza	PARP inhibitor	Approved in Ovarian Cancer

NCT04931342

Platinum resistant low-grade serous, low-grade endometrioid, clear cell, mucinous, undifferentiated, malignant Brenner tumors, small cell carcinoma of the ovary-hypercalcemic type or carcinosarcoma

A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

AZ, CA, MN, MO, NY, NC, OH, OK, OR, PA, TX, UT, VA, WA

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Drug(s) in Trial	Other Drug Names	Main Known Action	Drug Status
Abemaciclib	Bemaciclib, LY2853219, CDK4/6 Dual Inhibitor LY2835219, Verzenio	CDK4/6 inhibitor	Approved in Other Cancers
Atezolizumab	Tecentriq, Anti-PD-L1 Monoclonal Antibody MPDL3280A, MPDL3280A, RG7446	Blocks PD-L1 inhibition of T cells	Approved in Other Cancers
Bevacizumab	Avastin, anti-VEGF monoclonal antibody, immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain	VEGF antagonist	Approved in Ovarian Cancer
Cobimetinib	XL518, GDC-0973, Cotellic	MEK1 inhibitor	Approved in Other Cancers
Giredestrant	GDC-9545, selective estrogen receptor downregulator GDC-9545	ER antagonist (SERD)	Clinical Trials
Inavolisib	RG6114, GDC-0077	PI3K alpha inhibitor	Clinical Trials
Ipatasertib	GDC-0068, Akt Inhibitor GDC-0068, RG7440	pan-AKT inhibitor	Clinical Trials
Letrozole	Femara	Aromatase inhibitor	NCCN Guidelines for Ovarian Cancer
Olaparib	AZD2281, Lynparza	PARP inhibitor	Approved in Ovarian Cancer
Paclitaxel	Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL	Microtubule stabilizer/mitotic inhibitor	Approved in Ovarian Cancer
Palbociclib	PD-0332991, PD0332991, Ibrance	CDK4/6 inhibitor	Approved in Other Cancers
Trastuzumab emtansine	trastuzumab-MCC-DM1 immunoconjugate, trastuzumab-MCC-DM1 antibody-drug conjugate, trastuzumab-MCC-DM1, trastuzumab-DM1, T-DM1, Kadcyla, ado trastuzumab emtansine	ADC: anti-HER2 + microtubule destabilizer (DM1)	Approved in Other Cancers

NCT05238831

Recurrent ovarian cancer

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)

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Drug(s) in Trial	Other Drug Names	Main Known Action	Drug Status
Alectinib	AF802, anaplastic lymphoma kinase inhibitor CH5424802, Alecensa, ALK inhibitor CH5424802	ALK kinase inhibitor	Approved in Other Cancers
Alpelisib	PI3K inhibitor BYL719, BYL719, phosphoinositide 3-Kinase inhibitor BYL719, Piqray	PI3K alpha inhibitor	Approved in Other Cancers
Anastrozole	Arimidex	Aromatase inhibitor
Atezolizumab	Tecentriq, Anti-PD-L1 Monoclonal Antibody MPDL3280A, MPDL3280A, RG7446	Blocks PD-L1 inhibition of T cells	Approved in Other Cancers
Bevacizumab	Avastin, anti-VEGF monoclonal antibody, immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain	VEGF antagonist	Approved in Ovarian Cancer
Capecitabine	Xeloda, CAPE	RNA processing and thymidylate synthase inhibitor	NCCN Guidelines for Ovarian Cancer
Carboplatin	Paraplatin, Novoplatinum	DNA damaging agent	Approved in Ovarian Cancer
Cobimetinib	XL518, GDC-0973, Cotellic	MEK1 inhibitor	Approved in Other Cancers
Entrectinib	RXDX-101, TrkA/B/C/ROS1/ALK tyrosine kinase inhibitor RXDX-101, Rozlytrek	ALK, TRK, ROS1 kinase inhibitor	Approved in Other Cancers
Eribulin	B1939 mesylate, E7389, ER-086526, Halaven, halichrondrin B analog	Microtubule destabilizer/mitotic inhibitor	Approved in Other Cancers
Fulvestrant	Faslodex, ICI 182,780, ZD9238	ER antagonist (SERD)	Approved in Other Cancers
Irinotecan	Campothecin-11, Campto, Camptosar	Topoisomerase I inhibitor	NCCN Guidelines for Ovarian Cancer
Letrozole	Femara	Aromatase inhibitor	NCCN Guidelines for Ovarian Cancer
nab-Paclitaxel	Paclitaxel Albumin-Stabilized Nanoparticle Formula, Abraxane, ABI-007	Microtubule stabilizer/mitotic inhibitor	NCCN Guidelines for Ovarian Cancer
Niraparib	Zejula, MK4827	PARP inhibitor	Approved in Ovarian Cancer
Olaparib	AZD2281, Lynparza	PARP inhibitor	Approved in Ovarian Cancer
Paclitaxel	Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL	Microtubule stabilizer/mitotic inhibitor	Approved in Ovarian Cancer
Palbociclib	PD-0332991, PD0332991, Ibrance	CDK4/6 inhibitor	Approved in Other Cancers
Pertuzumab	Perjeta, monoclonal antibody 2C4, rhuMAb2C4	HER2 dimerization inhibitor	Approved in Other Cancers
Trastuzumab	Herceptin, Anti-erbB2 Monoclonal Antibody, HER2 Monoclonal Antibody	HER2 antagonist	Approved in Other Cancers
Trastuzumab emtansine	trastuzumab-MCC-DM1 immunoconjugate, trastuzumab-MCC-DM1 antibody-drug conjugate, trastuzumab-MCC-DM1, trastuzumab-DM1, T-DM1, Kadcyla, ado trastuzumab emtansine	ADC: anti-HER2 + microtubule destabilizer (DM1)	Approved in Other Cancers
Vemurafenib	RO5185426, PLX4032, Zelboraf	BRAF kinase inhibitor	Approved in Other Cancers
Vinorelbine	Biovelbin, Eunades, Navelbine, Navelbine ditartrate, NVB, Vinorelbine tartrate, VNB, Vinorelbine ditartrate	Microtubule destabilizer/mitotic inhibitor
Vismodegib	Hedgehog antagonist GDC-0449, Erivedge, GDC-0449	Smoothened antagonist	Approved in Other Cancers

NCT05295589

Platinum resistant or refractory high grade serous or endometrioid ovarian cancer or platinum resistant or refractory BRCA MUT ovarian cancer that must have had prior bevacizumab and must have progressed on prior PARP inhibitor therapy (≤ 2 prior therapies for platinum resistant disease)

A Randomized Phase II Trial Comparing the Combination of PI3K Inhibitor Copanlisib (BAY 80-6946) and PARP Inhibitor Olaparib (AZD2281) to Standard Chemotherapy in Patients With Recurrent Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Progressed Through Prior PARP Inhibitor Therapy

OK, RI

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Drug(s) in Trial	Other Drug Names	Main Known Action	Drug Status
Copanlisib	BAY 80-6946, PI3K inhibitor BAY 80-6946	pan-PI3K inhibitor	Approved in Other Cancers
Olaparib	AZD2281, Lynparza	PARP inhibitor	Approved in Ovarian Cancer

NCT03586661

Recurrent high grade serous ovarian cancer or BRCA MUT ovarian cancer that must have progressed after PARP inhibitor maintenance therapy (in expansion)

A Phase Ib Study of the Oral PARP Inhibitor Niraparib With the Intravenous PI3K Inhibitor Copanlisib for Recurrent Endometrial and Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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Drug(s) in Trial	Other Drug Names	Main Known Action	Drug Status
Copanlisib	BAY 80-6946, PI3K inhibitor BAY 80-6946	pan-PI3K inhibitor	Approved in Other Cancers
Niraparib	Zejula, MK4827	PARP inhibitor	Approved in Ovarian Cancer

NCT03842228

Advanced solid tumors with alterations in BARD1, BRCA1/2, BRIP1, FANCA, NBN, PALB2, PIK3CA (E542, E545 or H1047), PTEN, RAD51, RAD51B/C/D (in expansion)

A Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and Durvalumab (MEDI4736) in Patients With Advanced Solid Tumors

CO, MA, TX

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Drug(s) in Trial	Other Drug Names	Main Known Action	Drug Status
Copanlisib	BAY 80-6946, PI3K inhibitor BAY 80-6946	pan-PI3K inhibitor	Approved in Other Cancers
Durvalumab	Anti-B7H1 Monoclonal Antibody MEDI4736, MEDI4736, Imfinzi	Blocks PD-L1 inhibition of T cells	Approved in Other Cancers
Olaparib	AZD2281, Lynparza	PARP inhibitor	Approved in Ovarian Cancer

NCT04586335

Advanced solid tumors with mutations in DDR genes or PIK3CA, with no prior PARP inhibitor (inc ovarian expansion)

Open Label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of CYH33, an Oral PI3K Inhibitor in Combination With Olaparib, an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.

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Drug(s) in Trial	Other Drug Names	Main Known Action	Drug Status
CYH33		PI3K alpha inhibitor	Clinical Trials
Olaparib	AZD2281, Lynparza	PARP inhibitor	Approved in Ovarian Cancer

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