Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629781
Status:
TERMINATED
Last Update Posted:
2023-07-27
First Post:
2020-10-22
Brief Title:
Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With Metastatic Castration-resistant Prostate Cancer mCRPC
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
SAKK decided to premature terminate this trial as additional follow-up visits do not further contribute to the efficacy data This decision does not adversely impact the patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment with polysorbate 80-solved Docetaxel Taxotere is hampered by the requirement to co-administer steroids Chronic intermittent steroids are negatively impacting bone health and have well known immunosuppressive effects Despite steroid premedication polysorbate 80-solved Docetaxel Taxotere results in occasional infusion reactions due to the solvent polysorbate 80 Docetaxel micellar is a promising alternative to polysorbate 80-solved Docetaxel Taxotere as it avoids the mandatory need for steroid administration pre and post infusion and thus avoids immunosuppressive and bone-damaging effects
There is an unmet medical need to develop steroid-free taxane regimens for patients with advanced cancer to avoid the need for steroid administration pre and post infusion as outlined above The unique Docetaxel micellar formulation suggests an improved safety profile compared to polysorbate 80-solved Docetaxel Taxotere
There is an unmet medical need to develop steroid-free taxane regimens for patients with advanced cancer to avoid the need for steroid administration pre and post infusion as outlined above The unique Docetaxel micellar formulation suggests an improved safety profile compared to polysorbate 80-solved Docetaxel Taxotere
Detailed Description:
Docetaxel a semi-synthetic analogue of paclitaxel is one of the most widely used human anti-cancer agents Docetaxel and paclitaxel belong to a group of cytotoxic agents called taxanes Docetaxel has been marketed worldwide by Sanofi-Aventis under the trade name Taxotere and its use is approved for different types of solid tumors The efficacy of docetaxel has been proven in two different phase 3 trials in metastatic castration resistant prostate cancer mCRPC and is a standard of care option for patients with prostate cancer In Taxotere polysorbate 80 is used as surfactant Fluid retention and hypersensitivity reactions are reported and the patients are pre-treated with corticosteroids eg dexamethasone to avoid or at least reduce the frequency and the severity of both hypersensitivity reactions and fluid retention
Oasmia Pharmaceutical AB Uppsala Sweden has developed a novel formulation of docetaxel Docetaxel micellar with N-all-trans-retinoyl-L-cysteic acid methyl ester sodium salt XMeNa as excipient thus reducing adverse reactions caused by polysorbate 80 XMeNa forms micelles into which docetaxel can be incorporated thus increasing its aqueous solubility and keeping it dissolved
Rational Treatment with polysorbate 80-solved Docetaxel Taxotere is hampered by the requirement to co-administer steroid pre and post Taxotere infusion Chronic intermittent steroids are hurting bone health and have well known immunosuppressive effects Despite steroid premedication polysorbate 80-solved Docetaxel Taxotere results in occasional infusion reactions due to the solvent polysorbate 80 The new micellar formulation of docetaxel is a promising alternative to polysorbate 80-solved Docetaxel Taxotere as it avoids the mandatory need for steroid administration pre and post infusion and thus avoids immunosuppressive and bone-damaging effects
Safety and pharmacokinetics PK of Docetaxel micellar have been assessed in 2 clinical studies but only in breast cancer patients This is the first clinical trial to assess the safety and tolerability of 3-weekly intravenous Docetaxel micellar infusions in patients with mCRPC
The primary objective of this study is to determine the maximum tolerated dose MTD and the recommended phase II dose RP2D for Docetaxel micellar in patients with mCRPC
Oasmia Pharmaceutical AB Uppsala Sweden has developed a novel formulation of docetaxel Docetaxel micellar with N-all-trans-retinoyl-L-cysteic acid methyl ester sodium salt XMeNa as excipient thus reducing adverse reactions caused by polysorbate 80 XMeNa forms micelles into which docetaxel can be incorporated thus increasing its aqueous solubility and keeping it dissolved
Rational Treatment with polysorbate 80-solved Docetaxel Taxotere is hampered by the requirement to co-administer steroid pre and post Taxotere infusion Chronic intermittent steroids are hurting bone health and have well known immunosuppressive effects Despite steroid premedication polysorbate 80-solved Docetaxel Taxotere results in occasional infusion reactions due to the solvent polysorbate 80 The new micellar formulation of docetaxel is a promising alternative to polysorbate 80-solved Docetaxel Taxotere as it avoids the mandatory need for steroid administration pre and post infusion and thus avoids immunosuppressive and bone-damaging effects
Safety and pharmacokinetics PK of Docetaxel micellar have been assessed in 2 clinical studies but only in breast cancer patients This is the first clinical trial to assess the safety and tolerability of 3-weekly intravenous Docetaxel micellar infusions in patients with mCRPC
The primary objective of this study is to determine the maximum tolerated dose MTD and the recommended phase II dose RP2D for Docetaxel micellar in patients with mCRPC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None