Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

Part of paid clinical trials in Peoria, Arizona.

Sponsor
PharmaMar
Study ID
NCT02421588
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).

Key Dates

Start date
May 31, 2015
Status verified
Feb 2020
Primary completion
Oct 12, 2018
Completion
Oct 12, 2018

Study Design

Enrollment
442 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    lurbinectedin (PM01183)
  • Active Comparator: Arm B
    pegylated liposomal doxorubicin OR topotecan

Primary Outcome Measure

Progression-free Survival by Independent Review Committee [ Time Frame: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years ]

Locations (28)

FacilityCityStateZIPSite coordinators
1112PeoriaArizona--
1102GreenbraeCalifornia--
1103La JollaCalifornia--
1116Los AngelesCalifornia--
1120Los AngelesCalifornia--
1113Palo AltoCalifornia--
1111San FranciscoCalifornia--
1122Santa MariaCalifornia--
1123West HillsCalifornia--
1109AugustaGeorgia--
1104IndianapolisIndiana--
1110CovingtonLouisiana--
1124ScarboroughMaine--
1121BrickNew Jersey--
1127AlbanyNew York--
1105New YorkNew York--
1117AshevilleNorth Carolina--
1101CharlotteNorth Carolina--
1125CharlotteNorth Carolina--
1108DurhamNorth Carolina--
1107ColumbusOhio--
1118DaytonOhio--
1119PittsburghPennsylvania--
1115GreenvilleSouth Carolina--
1129NashvilleTennessee--
1131Fort WorthTexas--
1128HoustonTexas--
1106CharlottesvilleVirginia--

Find similar trials in Peoria, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
1112· Peoria, AZ1102· Greenbrae, CA1103· La Jolla, CA1116· Los Angeles, CA1120· Los Angeles, CA1113· Palo Alto, CA

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