NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Nektar Therapeutics
Study ID
NCT00856375
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • NKTR-102 — DRUG
    IV every 3 weeks
  • irinotecan — DRUG
    IV every 3 weeks

Study Details

This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.

Key Dates

Start date
Dec 31, 2008
Status verified
Jul 2021
Primary completion
Jul 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: NKTR-102
    NKTR-102 IV every 3 weeks
  • Active Comparator: irinotecan
    irinotecan IV every 3 weeks

Primary Outcome Measure

Kaplan-Meier Estimate of PFS by Central Radiological Review: ITT Population [ Time Frame: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study, approximately 42 months. ]

Locations (9)

FacilityCityStateZIPSite coordinators
Investigator Site - PeoriaPeoriaArizona85381-
Investigator Site - BurbankBurbankCalifornia91505-
Investigator Site - Los AngelesLos AngelesCalifornia90033-
Investigator Site - VallejoVallejoCalifornia94589-
Investigator Site - CentraliaCentraliaIllinois62801-
Investigator Site - LouisvilleLouisvilleKentucky40202-
Investigator Site - DetroitDetroitMichigan48201-
Investigator Site - BuffaloBuffaloNew York14215-
Investigator Site - KnoxvilleKnoxvilleTennessee37909-

Find similar trials in Peoria, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Investigator Site - Peoria· Peoria, AZInvestigator Site - Burbank· Burbank, CAInvestigator Site - Los Angeles· Los Angeles, CAInvestigator Site - Vallejo· Vallejo, CAInvestigator Site - Centralia· Centralia, ILInvestigator Site - Louisville· Louisville, KY

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