DoceAqualip (docetaxel nanosomal) / Intas, Jina Pharma - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients (clinicaltrials.gov) - P3 | N=657 | Recruiting | Sponsor: Jina Pharmaceuticals Inc. | Trial completion date: Jul 2024 ➔ Dec 2025 | Trial primary completion date: May 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Efficacy and safety of nanosomal docetaxel lipid suspension in Indian patients with metastatic castration-resistant prostate cancer (mCRPC): A multicenter, open-label, single-arm phase 4 study. (ASCO-GU 2025) - "NDLS showed efficacy and safety in patients with metastatic castration-resistant prostate cancer. Efficacy outcomes at cycle 10 completion.PR: partial response; SD: stable disease; BOR: Best overall response."

Clinical • Metastases • P4 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and efficacy of nanosomal docetaxel lipid suspension (NDLS) in patients with advanced gastric adenocarcinoma. (ASCO-GI 2024) - "Docetaxel, cisplatin, 5-fluorouracil (5-FU; DCF) or modified DCF (mDCF) is one of the recommended first-line regimens for patients with metastatic gastric adenocarcinoma (GAC)...Patients received either mDCF [NDLS 40 mg/m2 on day 1 (D1), C 40 mg/m2 on D2 or D3, 5-FU 400 mg/m2 bolus on D1, leucovorin 400 mg/m2 on D1, 5-FU 1000 mg/m2/day continuous infusion D1 & 2; q2w] for 9 cycles, or DCF [NDLS 75 mg/m2 on D1, C 75 mg/m2 on D1, 5-FU 750 mg/m2/day for 5 days given as continuous infusion; q3w] for 6 cycles... NDLS-based regimens demonstrated efficacy & improved safety profile in the treatment of metastatic GAC. Clinical trial information: CTRI/2018/01/011450. >NE: not estimable; NR: not reached."

Clinical • Metastases • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Nanosomal docetaxel lipid suspension (NDLS) or docetaxel based neoadjuvant therapy in Head and neck squamous cell carcinoma: Post hoc analysis of a prospective, randomized study (ESMO 2023) - "Background TPF (Docetaxel, Platinum & 5-Fluorouracil) or TP regimen as neoadjuvant chemotherapy (NACT) in head and neck cancer are associated with a high rate of adverse events. The efficacy was statistically similar between group 1 and 2 with respect to response rates (24.7% versus 29.6%, P=0.301), and median OS (10.1 [8.526-11.674] versus 11.37 [10.320-12.414], P=0.07). Any Grade Table: 897P Conclusions Use of NDLS formulation instead of conventional docetaxel leads to a decrease in adverse events like mucositis and neutropenia when used as neoadjuvant therapy in oral squamous cell carcinoma with similar efficacy."

Clinical • Retrospective data • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Induction chemotherapy with nanosomal docetaxel lipid suspension (NDLS), cisplatin, and fluorouracil in patients with locally advanced head and neck squamous cell carcinoma. (ASCO 2023) - "NDLS based induction chemotherapy was effective and well-tolerated in the treatment of inoperable LA HNSCC and showed high response rates. Clinical trial information: CTRI/2017/12/010938. >CI, confidence interval; CR, complete response; DCR, disease control rate; mITT, modified intent-to-treat; ORR, overall response rate; OS, overall survival; PFS, progression free survival; PP, per-protocol; PR, partial response; SD, stable disease."

Clinical • Metastases • Diabetes • Febrile Neutropenia • Head and Neck Cancer • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thrombocytopenia

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension (NDLS) versus Conventional Docetaxel as Neoadjuvant and Adjuvant Therapy for Primary Operable Breast Cancer. (PubMed, Onco Targets Ther) - "Patients received (1) four cycles of preoperative doxorubicin and cyclophosphamide (AC) followed by four cycles of NDLS or docetaxel (T) and surgery (neoadjuvant AC→NDLS [n=9], or neoadjuvant AC→T [n=10]), or (2) four cycles of preoperative AC followed by surgery and postoperative NDLS or T (neoadjuvant AC→adjuvant NDLS [n=14], or neoadjuvant AC→adjuvant T [n=15]), or (3) surgery followed by postoperative AC→NDLS or T (adjuvant AC→NDLS [n=7], or adjuvant AC→T [n=5]) regimens. NDLS-based neo/adjuvant chemotherapy was efficacious in the treatment of primary operable breast cancer and showed comparable pCR, ORR, DFS and OS rates versus conventional docetaxel. NDLS was better tolerated than conventional docetaxel."

Journal • Breast Cancer • Oncology • Solid Tumor

A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients (clinicaltrials.gov) - P3 | N=657 | Recruiting | Sponsor: Jina Pharmaceuticals Inc. | Unknown status ➔ Recruiting | Trial completion date: May 2022 ➔ Jul 2024 | Trial primary completion date: Mar 2022 ➔ May 2024

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Nanosomal docetaxel lipid suspension (NDLS) monotherapy is effective and well-tolerated in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy (ESMO 2022) - "Patients could be administered filgrastim support. Table: 1038P Response rate Conclusions NDLS monotherapy (75 or 100 mg/m 2 ) was effective and well-tolerated in the treatment of advanced NSCLC. NDLS demonstrated a dose dependent increase in efficacy from 75 to 100 mg/m 2 ."

Clinical • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Nanosomal docetaxel lipid suspension (NDLS) based (neo) adjuvant chemotherapy improves pathological complete response (pCR) in patients with breast cancer. (ASCO 2022) - "NDLS based neo/adjuvant chemotherapy was efficacious in the treatment of breast cancer and showed comparable pCR, CR and OS rates versus conventional docetaxel. NDLS was better tolerated than conventional docetaxel.AC, doxorubicin and cyclophosphamide; CR, complete response; NDLS, nanosomal docetaxel lipid suspension; pCR, pathologic complete response; PD, progressive disease; T, docetaxel. P=not significant for all comparisons."

Clinical • Breast Cancer • Diabetes • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • HER-2

Efficacy and safety of nanosomal docetaxel lipid suspension based chemotherapy in metastatic ovarian carcinoma: A retrospective study. (PubMed, Mol Clin Oncol) - "No grade III/IV adverse events (AEs) were observed; ≥1 AE in grade I-II was reported in 84.6% (11/13) of patients. Overall, NDLS-based chemotherapy was efficacious and well-tolerated in the management of metastatic epithelial ovarian carcinoma."

Clinical • Journal • Retrospective data • Oncology • Ovarian Cancer • Solid Tumor

[VIRTUAL] Incidence and severity of systemic allergic reactions (SAR) reported with chemotherapeutic drugs. (ASCO 2021) - "SAR was more observed with Paclitaxel (20.39%), Carboplatin (17.48%) and Rituximab (13.59%)...Among patients exhibiting SAR with Paclitaxel, 42.86% were switched to alternatives, Nab-paclitaxel (28.57%) being preferred the most . Carboplatin was changed to cisplatin in 16.66% patients and Nanosomal docetaxel lipid suspension replaced docetaxel in 42.86% patients who reported SAR with carboplatin and docetaxel respectively... The study inferred that most SAR reactions occurred with Paclitaxel and Carboplatin . Oxaliplatin and Carboplatin presented with delayed SAR . Grade 1 and grade 3 reaction were relatively more ."

Allergy • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Biweekly DoceAqualip in mCRPC patients beyond 20 cycles: A case series. (PubMed, J Oncol Pharm Pract) - "Biweekly NDLS for >20 cycles was effective and well-tolerated in patients with mCRPC. NDLS can potentially be used for long-term management, which may be a requirement for most patients with mCRPC."

Clinical • Journal • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

Letter to the Editor: "Docetaxel and its nanoformulations: how delivery strategies could impact the therapeutic outcome?" (PubMed, Ther Deliv) - No abstract available

Journal

A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer. (PubMed, Prostate Cancer) - "Overall, NDLS treatment was well tolerated without any new safety concerns. Nanosomal docetaxel lipid suspension (2-weekly or 3-weekly) was effective and well tolerated in patients with metastatic castration-resistant prostate cancer."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

Efficacy and safety of nanosomal docetaxel lipid suspension-based chemotherapy in squamous cell carcinoma of the head and neck: A multicenter retrospective study. (PubMed, Oncol Lett) - "No new safety concerns were reported. Overall, NDLS-based chemotherapy was effective and well tolerated in the treatment of SCCHN."

Journal • Retrospective data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy and safety of nanosomal docetaxel lipid suspension based chemotherapy in gastric and gastroesophageal junction adenocarcinoma. (PubMed, Mol Clin Oncol) - "NDLS based treatment was well-tolerated without any new safety concerns. Overall, NDLS-based chemotherapy was effective and well-tolerated in the management of gastric and GEJ adenocarcinoma."

Clinical • Journal • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • GastroEsophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • Thrombocytopenia

Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study. (PubMed, Breast Cancer (Dove Med Press)) - P3 | "Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of breast cancer. Further, NDLS is being evaluated prospectively in patients with triple-negative breast cancer (ClinicalTrials.gov: NCT03671044)."

Journal • Retrospective data • Breast Cancer • Diabetes • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study. (PubMed, Sarcoma) - "NDLS plus gemcitabine combination was used in 10 patients (90.9%), and NDLS plus cyclophosphamide was used in one patient with EMC (9.1%). Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of sarcoma. Further prospective trials are needed to confirm the data."

Journal • Retrospective data