Clinical trial · Interventional
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors
An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin Every 3 Weeks in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: * To assess the overall safety profiles of the combination therapy * To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination * To document the objective tumor response
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Ombrabulin (AVE8062) | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort - 1 through 5
- description
- AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks
- interventionNames
- Drug: Ombrabulin (AVE8062)
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1
- timeFrame
- 3 weeks
Secondary outcomes (24)
- measure
- The number of treatment emergent adverse events
- timeFrame
- 30 days after the last injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: * Patients with advanced solid tumor for which the combination paclitaxel and carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer. * Patients who have signed and dated an Institutional Review Board (IRB)-approved patient informed consent form prior to study enrollment or performance of any study-specific procedures. Exclusion criteria: * Less than 20 or above 75 years of age ECOG performance status ≥2. * Patients with more than 1 line of previous chemotherapy for advanced or metastatic disease (adjuvant/neoadjuvant and targeted agents \[eg gefitinib\] excluded) * Concurrent treatment with any other anticancer therapy (except palliative radiotherapy), * Women of childbearing potential who does not agree with contraception. * Washout period of less than 28 days from prior anticancer therapies * Symptomatic brain metastases and carcinomatous leptomeningitis. * Other serious illness or medical conditions * Current peripheral neuropathy ≥grade 2 and ototoxicity, * Absolute neutrophils counts\<1.5 x 10E9/L. - Platelets count\<100 x 10E9/L. - hemoglobin \<9.0 g/dL (without red blood cell transfusion within 28 days before the test). - Creatinine Clearance\<55 mL/min. - Total bilirubin \>upper normal limits of the institutional norms. - ALT/AST \>1.5 times the upper normal limits of the institutional norms. - AP\>2.5 times the upper normal limits of the institutional norms. * Medical history of myocardial infarction, angina pectoris, congestive heart failure, coronary artery bypass graft , arrhythmia , stroke or history of arterial or venous thrombo-embolism within the past 180 days requiring anticoagulants. * Patient with a LVEF \<50% by echocardiography. * Patient with uncontrolled hypertension and patient with organ damage related to hypertension such as left ventricular hypertrophy or grade 2 ocular fundoscopic changes or kidney impairment. * Hypertension defined as systolic BP \>140 mmHg or diastolic BP \>90 mmHg on two repeated measurements at 30 minutes interval. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (1)
- DERIVEDMatsumoto 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. PMID 37989482