gemcitabine oral (D07001) / Synmosa Biopharma - LARVOL DELTA

D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P3 | N=195 | Not yet recruiting | Sponsor: InnoPharmax Inc. | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Phase I study of oral metronomic gemcitabine (D07001) in patients with advanced solid tumors. (PubMed, Oncologist) - "Our study demonstrated that D07001-softgel capsules can be safely administered as continuous dosing of up to 100 mg in patients with advanced solid tumors. Further studies are warranted to determine the appropriate dose in combination with other chemotherapy drugs."

Journal • P1 data • Anorexia • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Solid Tumor

D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P3 | N=195 | Not yet recruiting | Sponsor: InnoPharmax Inc.

New P3 trial • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase (clinicaltrials.gov) - P1/2 | N=19 | Completed | Sponsor: InnoPharmax Inc. | Terminated ➔ Completed

Trial completion • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Solid Tumor

Uromigos Live 2023 Bladder: Was CheckMate 901 a "Black Swan Event" or Should We Have Seen It Coming? (YouTube) - "In the first part of The Uromigos Live 2023 bladder cancer panel 1, Drs. Brian Rini, Thomas Powles...Shilpa Gupta...Matthew Galsky explore frontline data presented at ESMO, including cisplatin plus nivolumab in the CheckMate 901 study, and how much of the benefit shown with cisplatin plus gemcitabine is from maintenance nivolumab."

Video

First-Line NALIRIFOX Demonstrates Survival Advantage Over Standard Gemcitabine/Paclitaxel in Metastatic PDAC (OncLive) - "Eileen M. O'Reilly, MD, expands on the updated survival data from NAPOLI-3, explains how NALIRIFOX could fit into the current pancreatic ductal adenocarcinoma treatment paradigm, and shares potential opportunities to build upon this research moving forward."

Interview

Phase 1 studies of D07001-F4 and D07001-softgel capsule: Oral metronomic gemcitabine in subjects with advanced solid tumors. (ASCO 2023) - P1, P1/2 | "The results suggest the feasibility of oral gemcitabine treatment with D07001-softgel capsules, which is well-tolerated for continuous dosing and deserves further clinical investigation. Clinical trial information: NCT01800630, NCT03531320."

Clinical • Metastases • P1 data • Anorexia • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Solid Tumor

Metastatic urothelial carcinoma: Eribulin, with or without gemcitabine, to treat the second most deadly GU cancer (SWOG-Spring 2023) - No abstract available.

Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: InnoPharmax Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

New drug combination lengthened survival for some with lung cancer (Eurekalert) - "A study conducted under the Lung Cancer Master Protocol (Lung-MAP) found that patients with advanced non-small cell lung cancer whose cancer had progressed on previous immunotherapy lived significantly longer when treated with a combination of ramucirumab (Cyramza) plus pembrolizumab (Keytruda) than when treated with one of the current standard therapies for this type of cancer....'This is the first trial to show a survival benefit with ICI and VEGFR inhibition for patients with advanced lung cancer who have experienced tumor progression on prior ICI,' Reckamp said....Liza Villaruz, MD...Vassiliki Papadimitrakopoulou, MD...David R. Gandara...Karen Kelly...Roy S. Herbst..."

Media quote

Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2/3 | N=180 | Not yet recruiting | Sponsor: InnoPharmax Inc. | Initiation date: Nov 2021 ➔ Apr 2022

Combination therapy • Trial initiation date • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2/3; N=180; Not yet recruiting; Sponsor: InnoPharmax Inc.

Clinical • Combination therapy • New P2/3 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MRI

Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase (clinicaltrials.gov) - P1/2; N=19; Terminated; Sponsor: InnoPharmax Inc.; N=70 ➔ 19; Trial completion date: Apr 2022 ➔ Dec 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Jun 2021 ➔ Dec 2020; The Sponsor is considering revising the protocol design of the Part II study, so it has decided not to continue the Part II of the study at this stage.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Solid Tumor