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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-2568 | Other Identifier | UTN |
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The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors.
Secondary Objectives:
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort - 1 through 5 | Experimental | AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ombrabulin (AVE8062) | Drug | Pharmaceutical form:solution Route of administration: intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1 | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of treatment emergent adverse events | 30 days after the last injection | |
| The number of serious adverse events | 30 days after the last injection | |
| The number of laboratory abnormalities |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392002 | Akashi-Shi | Japan | ||||
| Investigational Site Number 392001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37989482 | Derived | Matsumoto K, Sunaga Y, Ecstein-Fraisse E, Fujiwara K. Phase I study of ombrabulin in combination with paclitaxel and carboplatin in Japanese patients with advanced solid tumors. Int J Gynecol Cancer. 2024 Apr 1;34(4):586-593. doi: 10.1136/ijgc-2022-003880. |
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| ID | Term |
|---|---|
| C400245 | AC 7700 |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | Pharmaceutical form:solution Route of administration: intravenous |
|
| Carboplatin | Drug | Pharmaceutical form:solution Route of administration: intravenous |
|
| 30 days after the last injection |
| Pharmacokinetic parameter of ombrabulin: Cmax | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of RPR258063: tmax | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of paclitaxel: Cmax | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of carboplatin (free and total platinum): Cmax | Day 1-3 at Cycle 1 |
| Investigator determination of response | 30 days after the last injection |
| Pharmacokinetic parameter of ombrabulin: AUC | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of ombrabulin: CL | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of ombrabulin: Vss | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of ombrabulin: t 1/2 | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of RPR258063: Cmax | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of RPR258063: AUC | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of RPR258063: t 1/2 | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of RPR258063: Metabolic Ratio | Day 1-2 at Cycle 1 |
| Pharmacokinetic parameter of paclitaxel: AUC | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of paclitaxel: CL | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of paclitaxel: Vss | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of paclitaxel: t 1/2 | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of carboplatin (free and total platinum): AUC | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of carboplatin (free and total platinum): CL | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of carboplatin (free and total platinum): Vss | Day 1-3 at Cycle 1 |
| Pharmacokinetic parameter of carboplatin (free and total platinum): t 1/2 | Day 1-3 at Cycle 1 |
| Hidaka-Shi |
| Japan |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |