The company currently has two ongoing open-label clinical trials: a phase Ib/II trial in acute myeloid leukemia and a phase II trial in metastatic castration-resistant prostate cancer. Combining Onvansertib with Standard-of-Care Decitabine is Providing a New Treatment Option that is Demonstrating Safety and Efficacy in the Relapsed and Refractory Clinical Setting. On June 8, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that the first patient has been dosed in its Phase 2 clinical trial of onvansertib in . This arm was discontinued. The Polo-like kinase 1 inhibitor onvansertib represents a ... Accessed October . TrovaGene (TROV) Stock Runs For The Top On Onvansertib Data Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Data Demonstrate the Clinical Benefit of Onvansertib in KRAS-Mutated mCRC. Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are . Data from a phase 1b/2 study investigating . Add-on onvansertib overcomes resistance to Zytiga in ... Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga® (NCT03414034); a . Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support The first type of trials are Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or . Purpose: The Polo-like kinase 1 (PLK1) is a master regulator of mitosis and overexpressed in acute myeloid leukemia (AML). Onvansertib Regimen Shows Early Promise in KRAS-Mutant mCRC Florida)-? Danielle Ternyila. February 4, 2020. Dr. David Einstein, principal investigator . PDF A phase 1b study of onvansertib, a novel oral PLK1 ... and . Preclinical data suggested that onvansertib significantly boosts the efficacy of Zytiga in animal models of mCRPC. This trial is an open-label, multi-center study designed to assess the safety and efficacy of onvansertib in combination with . Hence, testing onvansertib in clinical trials to increase the lifespan of HNSCC patients represents an important follow-up of our experiments. Onvansertib, a first-in-class, third-generation, oral adenosine triphosphate, is also being evaluated in other clinical trials for malignancies like prostate cancer, non-Hodgkin lymphoma, colorectal cancer, triple-negative breast cancer, and others. In addition, the company develops therapeutics, such . Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga® (NCT03414034); a . About the Phase 1b/2 Clinical Trial of Onvansertib in mCRC In this open-label, Phase 1b/2 trial, onvansertib in combination with standard-of-care FOLFIRI and Avastin® is being evaluated for . This percentage was an improvement from the 5% to 13% ORR that was historically observed with the SOC. The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily, for 5 consecutive days on Day 1-5 of each 14-day course in each 28-day cycle, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga® (NCT03414034); a . Onvansertib (NMS-P937) potently causes a mitotic cell-cycle arrest followed by apoptosis in cancer cell lines and inhibits tumor growth. The company's onvansertib is also in Phase 2 clinical trial in combination with Zytiga for metastatic castration-resistant prostate cancer. Clinical trial identification [NCT03829410][1]. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. In this open-label, Phase 1b /2 trial, onvansertib in combination with standard-of-care FOLFIRI and Avastin® . Onvansertib in combination with FOLFIRI/bevacizumab has been well tolerated with no major or unexpected toxicities attributed to onvansertib Key Opinion Leader Webinar The updated Phase 1b /2 mCRC trial data will be presented during a key opinion leader (KOL) webinar taking place today, April 12, 2021 at 11:00 a.m. In an early-morning press release, Trovagene announced positive results from an ongoing Phase 1b/2 clinical trial of onvansertib in combination with FOLFIRI and Avastin. Adding the investigational oral therapy onvansertib to a regimen of Zytiga (abiraterone acetate) and prednisone overcomes resistance to Zytiga in men with metastatic castration-resistant prostate cancer (mCRPC), according to early results of a Phase 2 clinical trial.. Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved. in-vivo. Dr. Mark Erlander, CEO of Cardiff Oncology discusses their lead drug candidate Onvansertib and the three active clinical trials in colorectal cancer, acute myeloid leukemia, and prostate cancer. "This designation is a significant validation of not only our onvansertib clinical program, which is now eligible for priority review and accelerated approval, but it also signifies recognition of the medical need for new effective treatment options.". Participant is NOT eligible for other clinical trials currently open in the region Participant has failed or progressed on standard of care systemic therapy FOLFIRI (with or without 5FU bolus and continuous infusion)/bevacizumab plus onvansertib is appropriate for the participant as determined by the treating physician, including participants . Onvansertib has potent . Biochemical assays demonstrated high-specificity of onvansertib for PLK1 among a panel of 296 kinases, including other PLK members (16). The Phase 2 open-label, multicenter trial, which is an integral part of Cardiff Oncology's focus on KRAS-mutated solid tumor cancers, is designed to assess the safety and preliminary efficacy of onvansertib in combination with standard-of-care as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. Onvansertib, its lead drug candidate, is a first-in-class, 3rd generation, highly-selective oral Polo-like Kinase 1 Inhibitor. May 28, 2020. Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga® (NCT03414034); a . Minnesota-? Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Updated September 30, 2020. Trovagene launched a Phase 2 clinical trial ( NCT03414034) to evaluate whether adding onvansertib to the standard Zytiga combination could halt cancer progression and extend survival. Nichole Tucker. Onvansertib specifically targets and inhibits a downstream enzyme, PLK1, effectively stopping cancer . Onvansertib Triplet Shows Promise in KRAS-Mutant Metastatic Colorectal Cancer. This Phase 2 clinical trial is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide ®), 5-FU and leucovorin as a second-line . About the Phase 1b /2 Clinical Trial of Onvansertib in KRAS-Mutated mCRC The ongoing trial, A Phase 1b /2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second‑Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation ( NCT03829410 ) is evaluating the safety and efficacy of onvansertib in . Onvansertib (NMS-P937, PCM-075, NMS1286937) is an orally available, selective Polo-like Kinase 1 (PLK1) inhibitor with IC50 of 2 nM, 5000-fold selectivity over PLK2/PLK3. Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are . We hear that an investigational drug called onvansertib — a so-called polo-like kinase 1 (PLK1) inhibitor — may have benefit in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) who are showing early signs of progression on treatment with abiraterone acetate (Zytiga) + prednisone.. Onvansertib Regimen Shows Early Promise in KRAS-Mutant mCRC. It is enrolling up to 64 men with mCRPC showing . Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone. Onvansertib Regimen Shows Early Promise in KRAS-Mutant mCRC. ClinicalTrials.gov. - Trial represents a key component of onvansertib's KRAS-targeted clinical programs and is designed to leverage the synergy of onvansertib when combined with irinotecan/5-FU May 20, 2021 Cardiff Oncology to Present at the Jefferies Virtual Healthcare Conference Onvansertib Receives FDA Fast Track Designation in KRAS+ mCRC. There are also less common very early (phase 0) and later (phase 4) phases. Phase 1. NCT03829410. Complete title: An Expanded Access Treatment Plan for the Use of Onvansertib (PCM-075) in a Single Patient with Acute Myeloid Leukemia Trial phase: Phase N/A Local study ID: RG1121890 Enrollment status: Recruiting . Heinz-Josef Lenz, MD, FACP, discusses the next steps for the trial examining the onvansertib combination and sheds light on the . Trovagene has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga® (NCT03414034); a Phase 1b /2 . Onvansertib is an orally bioavailable, adenosine triphosphate competitive inhibitor of polo-like kinase 1 (PLK1; PLK-1; STPK13), with potential antineoplastic activity.Upon administration, onvansertib selectively binds to and inhibits PLK1, which disrupts mitosis and induces selective G2/M cell-cycle arrest followed by apoptosis in PLK1-overexpressing tumor cells. Phase 2 and 3 Clinical Trials that Require FDA-IND or IDE Application This protocol template aims to facilitate the development of two types of clinical trials involving human participants. Kansas University?Medical . The Cardiff Oncology EAP in KRAS-mutated mCRC is using the same combination treatment regimen (onvansertib 15 mg/m 2 + FOLFIRI/bevacizumab) and dosing schedule as the ongoing Phase 1b /2 clinical . in-vitro. Citation Format: Afsaneh Barzi, Heinz-Josef Lenz, Errin Samuëlsz, Maya Ridinger, Mark Erlander, Tanios S. Bekaii-Saab, Daniel H. Ahn. The ongoing trial, A Phase 1b /2 Study of Onvansertib (PCM-075) . The Cardiff Oncology EAP in KRAS-mutated mCRC is using the same combination treatment regimen (onvansertib 15 mg/m 2 + FOLFIRI/bevacizumab) and dosing schedule as the ongoing Phase 1b /2 clinical trial and is intended for patients that have progressed on prior therapy and do not meet the eligibility criteria for enrollment in the clinical trial . Onvansertib in combination with abiraterone and prednisone in adult patients with metastatic castration-resistant prostate cancer. The study will be conducted at six clinical trial sites across the U.S: Mayo Clinic (Arizona-? Synergistic in Combination. Phase 1b/2 multi-center open-label clinical trial NCT03303339 Phase 3 trials include large numbers of people to make sure that the result is valid. Onvansertib (also known as PCM-075 or NMS-1286937) is a selective ATP-competitive PLK1 inhibitor. Introduction. anti-tumor Trovagene has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are showing . In an interview with Targeted Oncology, Daniel H. Ahn, DO, discussed the phase Ib/II study of onvansertib plus FOLFIRI and bevacizumab for the treatment of patients with metastatic colorectal cancer with a KRAS mutation. Cardiff Oncology - Onvansertib clinical trials. About the Phase 1b/2 Clinical Trial of Onvansertib in KRAS-Mutated mCRC The ongoing trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second‑Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation ( NCT03829410 ) is evaluating the safety and efficacy of onvansertib in . The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily, for 5 consecutive days on Day 1-5 of each 14-day course in each 28-day cycle, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras . About the Phase 2 Trial of Onvansertib in Metastatic PDAC. This Phase 2 clinical trial is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide ®), 5-FU and leucovorin as a second-line . Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS . Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Onvansertib Works Synergistically in Combination with Chemotherapies and Targeted Therapeutics. 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