Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03095612
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Selinexor once weekly oral or twice weekly oral
  • Docetaxel — DRUG
    Docetaxel once every 3 weeks (75 mg/m2 IV)

Study Details

This study is being done to evaluate the safety of the investigational study drug, selinexor when given with docetaxel to patients who have been previously treated for advanced KRAS mutant lung cancer.

Key Dates

Start date
Mar 22, 2018
Status verified
Jun 2024
Primary completion
Nov 8, 2022
Completion
Mar 3, 2023

Study Design

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

Arms

  • Experimental: Selinexor Monotherapy and in Combination with Docetaxel
    For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly). Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 40 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Each 21 day cycle for 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045-
University of Pittsburgh Medical Center-Hillman Cancer CenterPittsburghPennsylvania15232-
University of Vanderbilt Medical Center-Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75063-
University of Washington-Seattle Cancer Care AllianceSeattleWashington98195-

Find similar trials in Aurora, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Colorado Cancer Center· Aurora, COUniversity of Pittsburgh Medical Center-Hillman Cancer Center· Pittsburgh, PAUniversity of Vanderbilt Medical Center-Vanderbilt-Ingram Cancer Center· Nashville, TNUniversity of Texas Southwestern Medical Center· Dallas, TXUniversity of Washington-Seattle Cancer Care Alliance· Seattle, WA

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