Paclitaxel 6 mg/ml concentrate for solution for infusion
Sponsors
Vastra Gotalandsregionen, Gilead Sciences Inc., Tesaro Inc., F. Hoffmann-La Roche AG, Alx Oncology Inc.
Conditions
Advanced MalignanciesAdvanced pancreatic cancerBreast CancerEarly stage HER2-positive breast cancerLocally Advanced or Metastatic Unresectable Urothelial CancerLocally advanced or metastatic hormone receptor (HR)-positiveLuminal B Breast CancerMetastatic Urothelial Carcinoma
Phase 2
OPAL Master Protocol: A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of Treatments in Participants with Ovarian Cancer (OPAL) (PR-3000-02-005/213357)
Cohort C: Open-label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants with Homologous Recombination- Deficient Stage III/IV Ovarian Cancer
CompletedCTIS2023-505097-16-00
Start: 2022-04-04End: 2025-03-31Target: 15Updated: 2025-01-14
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
Active, not recruitingCTIS2023-508194-89-00
Start: 2021-08-30Target: 57Updated: 2026-01-06
A Phase 2/3 Study of ALX148 in Patients with Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
Active, not recruitingCTIS2023-509406-30-00
Start: 2022-01-24Target: 87Updated: 2026-01-22
Single arm phase 2 trial of neoadjuvant trastuzumab deruxtecan (T-DXd) with response-directed definitive therapy in early stage HER2-positive breast cancer: a standard chemotherapy-sparing approach to curative-intent treatment – SHAMROCK study
SuspendedCTIS2024-516582-36-00
Start: 2025-03-25Target: 77Updated: 2025-02-24
Neo-adjuvant chemotherapy combined with Stereotactic Body Radiotherapy to the primary tumour +/- durvalumab (MEDI4736), +/- oleclumab (MEDI9447) in luminal B breast cancer: a phase ll randomised trial
Active, not recruitingCTIS2024-511849-19-00
Start: 2019-10-17Target: 147Updated: 2025-05-06
A Phase 2 Study of Novel Combination Therapies in Participants With Previously Untreated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status
SuspendedCTIS2024-513121-22-00
Start: 2025-02-04Target: 21Updated: 2026-01-27
A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination with Budigalimab Versus Chemotherapy in Subjects with Metastatic Urothelial Carcinoma
RecruitingCTIS2024-515506-11-00
Start: 2025-03-24Target: 60Updated: 2025-12-09
A Phase II, Open-Label, Single-Arm, Multicentre Study of Carboplatin, Paclitaxel, and Tislelizumab in Biomarker-Selected Patients with Resectable Locally Advanced Oral Cavity Squamous Cell Carcinoma - PERSEPHONE Trial
Not yet recruitingCTIS2024-517565-16-00
Target: 28Updated: 2026-01-16
A Phase II, Open-Label, Single-Arm, Multicentre Study of Carboplatin, Paclitaxel, and Tislelizumab in Biomarker-Selected Patients with Resectable Locally Advanced Oral Cavity Squamous Cell Carcinoma - PERSEPHONE Trial
Not yet recruitingCTIS2024-517565-16-00
Target: 28Updated: 2026-01-16
Master Protocol: A Phase 1b / 2, Multicenter, Multi Arm Study of Evorpacept in Combination with Anti-cancer Therapies in Advanced / Metastatic Malignancies (ASPEN-09)
Substudy Protocol: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination with Trastuzumab and Chemotherapy in Participants with Metastatic HER2-Positive Breast Cancer (ASPEN-09-03)
Not yet recruitingCTIS2025-522012-16-00
Target: 36Updated: 2026-01-23
Phase 3
Standard versus Prolonged Neoadjuvant (Conversion) Chemotherapy to prolong survival of patients with Borderline and Locally Advanced Pancreatic Cancer: a phase III randomized controlled trial; ADVANTAGE
RecruitingCTIS2022-502117-29-00
Start: 2023-10-19Target: 754Updated: 2025-12-15
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Active, not recruitingCTIS2022-502593-17-00
Start: 2023-09-19Target: 428Updated: 2025-11-24
An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)
Active, not recruitingCTIS2023-506184-34-00
Start: 2019-08-09Target: 104Updated: 2025-11-10
A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum.
Active, not recruitingCTIS2024-516530-36-00
Start: 2025-01-08Target: 20Updated: 2025-10-14
The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
CompletedCTIS2024-517251-12-00
Start: 2021-11-02End: 2025-06-16Target: 202Updated: 2025-08-04
A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti- PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer
CompletedCTIS2024-515051-38-00
Start: 2018-07-20End: 2025-02-27Target: 117Updated: 2024-12-10
A Global, Randomized, Phase 3, Open-Label Study of REGN2810 (Anti-PD-1 Antibody) versus Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic PD-L1 + Non-Small Cell Lung Cancer
CompletedCTIS2024-515052-20-00
Start: 2017-09-20End: 2025-04-18Target: 68Updated: 2024-12-10
MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum- Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
CompletedCTIS2024-516111-25-00
Start: 2020-11-09End: 2024-10-29Target: 1Updated: 2024-10-15
Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer
CompletedCTIS2024-513870-23-00
Start: 2021-06-28End: 2025-05-21Target: 391Updated: 2025-05-13
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
Active, not recruitingCTIS2023-504194-21-00
Start: 2022-09-13Target: 114Updated: 2026-01-12
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Active, not recruitingCTIS2023-504195-14-00
Start: 2022-08-31Target: 167Updated: 2025-12-12