Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors

Part of paid clinical trials in New York, New York.

Sponsor
PharmaMar
Study ID
NCT01831089
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PM01183 + paclitaxel +/- bevacizumab — DRUG
    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

Study Details

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

Key Dates

First listed
Apr 15, 2013
Start date
Sep 30, 2013
Status verified
Mar 2020
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
69 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    PM01183 + paclitaxel +/- bevacizumab

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
-New YorkNew York--

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