CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 69 enrolled
Drug / intervention
PM01183 + paclitaxel +/- bevacizumabdrug
Likely dose
PM01183 + paclitaxel +/- bevacizumab 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01831089
NCT01831089Phase 1Completed
CompareCT.gov

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors

PharmaMar·interventional·Posted Apr 15, 2013·Updated Apr 10, 2020

In Brief

A Phase 1 clinical trial evaluating PM01183 + paclitaxel +/- bevacizumab for Breast Cancer and 6 related conditions. Completed, enrolled 69 participants across 3 sites in 3 countries.

Detailed Summary

Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Ovarian Cancer, Gynecological Cancer, Head and Neck Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Non-squamous Cell Lung Cancer
CountriesSpain, Switzerland, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2013
Enrollment StartSep 1, 2013
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.2 years ago

Interventions

PM01183 + paclitaxel +/- bevacizumabdrug

PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion paclitaxel: 6 mg/ml concentrate for solution for infusion bevacizumab: 25 mg/ml concentrate for solution for infusion Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients