BRCA mutations and gastrointestinal cancers: When to expect the unexpected?

Table 1 Ongoing trials including patients carrying gastro-intestinal cancer with BRCA1m and/or BRCA2m and solid tumours with BRCA1m and/or BRCA2m

	Study title	Design	Status	Trial description
NCT03337087	Liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib in treating patients with metastatic pancreatic, colorectal, gastroesophageal, or biliary cancer	Phase I	Recruiting	Experimental: nal-IRI, leucovorin, fluorouracil, rucaparib
NCT02286687	Talazoparib in treating patients with recurrent, refractory, advanced, or metastatic cancers and alterations in the BRCA genes	Phase IIa	Recruiting	Experimental: Talazoparib
NCT03428802	Pembrolizumab in treating participants with metastatic, recurrent or locally advanced cancer and genomic instability	Phase IIa	Recruiting	Experimental: Pembrolizumab
NCT04503265	A trial of AMXI-5001 for treatment in patients with advanced malignancies	Phase I-IIa	Recruiting	Experimental: AMXI-5001 (oral PARP and microtubule polymerization inhibitor)
NCT04171700	A study to evaluate rucaparib in patients with solid tumors and with deleterious mutations in HRR genes (LODESTAR)	Phase IIa	Recruiting	Experimental: Rucaparib
NCT03415659	Phase I clinical study of HWH340 tablet in patients with advanced solid tumors	Phase I	Recruiting	Experimental: HWH340 monotherapy
NCT02723864	Veliparib (ABT-888), an Oral PARP inhibitor, and VX-970, an ATR inhibitor, in combination with cisplatin in people with refractory solid tumors	Phase I	Active, not recruiting	Experimental: VX-970 at Days 2 and 9 of each 21-d cycle; veliparib twice a day (BID) days 1-3 and 8-10 of each cycle; cisplatin at day 1 (and day 8 from DL3 onwards) of each cycle
NCT00516373	A study to assess the safety and pharmacokinetics of an inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)	Phase I	Active, not recruiting	Experimental: KU-0059436 (oral PARP inhibitor)
NCT04439227	Testing AZD1775 as a potential targeted treatment in cancers with BRCA genetic changes (MATCH-Subprotocol Z1I)	Phase II	Active, not recruiting	Experimental: Adavosertib
NCT03565991	Javelin BRCA/ATM: Avelumab plus talazoparib in patients with BRCA or ATM mutant solid tumors	Phase II	Active, not recruiting	Experimental: Combination of avelumab and talazoparib
NCT01482715	A study of oral rucaparib in patients with a solid tumor (Phase I) or with gBRCA mutation ovarian cancer (Phase II)	Phase I-IIa	Completed	Experimental: Rucaparib
NCT01989546	Pilot trial of BMN 673, an oral PARP Inhibitor, in patients with advanced solid tumors and deleterious BRCA mutations	Phase I-IIa	Completed	Experimental: Talazoparib (BMN 673)
NCT01286987	Study of Talazoparib, a PARP Inhibitor, in patients with advanced or recurrent solid tumors	Phase I	Completed	Experimental: Talazoparib
NCT03767075	A modular multi-basket trial to improve personalized medicine in cancer patients (BoB)	Phase II	Recruiting	Experimental: Atezolizumab

nal-IRI: Lyposomal irinotecan; PARP: Poly-ADP ribose polymerase; ATR: Ataxia telangiectasia and Rad3-related protein; ATM: Ataxia telangiectasia mutated; BID: Bis in die; DL3: Dose level 3; BoB: Basket of baskets.