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

NCT00856375 | Completed Phase 2 Results DMC

• 1 other identifier: 08-PIR-03
• Study Type: interventional
• Target: 83
• Locations: 6 countries
• Sites: 24

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; Colorectal cancer, second line

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier Estimate of PFS by Central Radiological Review: ITT Population

  PFS was defined as the time from the date of randomisation to the date of disease progression (assessed by central radiological review according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) or death due to any cause, whichever comes first. PFS was determined using the intention-to-treat (ITT) population which included all randomized patients who underwent baseline evaluation, with treatment assigned according to randomized arm. For patients whose disease did not progress or who did not die, the PFS time was censored at the time of the last tumor assessment that demonstrated lack of disease progression. For patients who received new anti-cancer therapy, the PFS time was censored at the time of last tumor assessment prior to the new anti-cancer therapy starts.

  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.

Secondary Outcomes (5)

• Kaplan-Meier Estimate of OS: ITT Population

  From randomization to death, loss to follow-up, withdrawal of consent for further follow-up for survival, or end of study, approximately 42 months.

• ORR by Central Radiological Review: ITT Population

  From randomization of the first subject until documented disease progression, start of new therapy for cancer, death, or end of study approximately 42 months

• DoR by Central Radiological Review: ITT Population

  From the time measurement criteria for CR/PR (whichever was first recorded) were first met until the first date that recurrent disease or PD or death was objectively documented, assessed until the end of study approximately 42 months

• Percentage of Participants (≥2%) With Treatment-Emergent Adverse Events NCI-CTCAE Grade 3 or Higher

  From the first dose of study medication through the End-of-Treatment visit (30 ± 3 days from last dose of study drug), assessed until the end of study approximately 42 months

• PK Parameters of NKTR-102 or Irinotecan and Respective Metabolites

  Days 1, 2, 3, 4, 8 and 15 of Cycles 1 and 3 and Day 1 of Cycles 2, 4 and all subsequent cycles, until End of Study, approximately 42 months.

Study Arms (2)

NKTR-102

EXPERIMENTAL

NKTR-102 IV every 3 weeks

Drug: NKTR-102

irinotecan

ACTIVE COMPARATOR

irinotecan IV every 3 weeks

Drug: irinotecan

Interventions

NKTR-102 DRUG

IV every 3 weeks

Also known as: etirinotecan pegol

NKTR-102

irinotecan DRUG

IV every 3 weeks

irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• metastatic colorectal cancer
• tumor with k-ras mutation

You may not qualify if:

• More than 1 prior regimen for treatment of metastatic disease

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (24)

Investigator Site - Peoria

Peoria, Arizona, 85381, United States

Location

Investigator Site - Burbank

Burbank, California, 91505, United States

Location

Investigator Site - Los Angeles

Los Angeles, California, 90033, United States

Location

Investigator Site - Vallejo

Vallejo, California, 94589, United States

Location

Investigator Site - Centralia

Centralia, Illinois, 62801, United States

Location

Investigator Site - Louisville

Louisville, Kentucky, 40202, United States

Location

Investigator Site - Detroit

Detroit, Michigan, 48201, United States

Location

Investigator Site - Buffalo

Buffalo, New York, 14215, United States

Location

Investigator Site - Knoxville

Knoxville, Tennessee, 37909, United States

Location

Investigator Site - Antwerp

Antwerp, 2020, Belgium

Location

Investigator Site - Celle

Celle, 29223, Germany

Location

Investigator Site - Karlsruhe

Karlsruhe, 48201, Germany

Location

Investigator Site - Hyderabad

Hyderabad, Andhra Pradesh, 500004, India

Location

Investigator Site - Ahmedabad

Ahmedabad, Gujarat, 380009, India

Location

Investigator Site - Bangalore

Bangalore, Karnatak, 560054, India

Location

Investigator Site - Bangalore

Bangalore, Karnatak, 560078, India

Location

Investigator Site - Kochi

Kochi, Kerata, 682041, India

Location

Investigator Site - Mumbai

Mumbai, Maharashtra, 91-98-50986003, India

Location

Investigator Site - Kolkata

Kolkata, West Benagal, 700026, India

Location

Investigator Site - Kolkata

Kolkata, West Bengal, 700053, India

Location

Investigator Site - Elche

Elche, 34-966-616250, Spain

Location

Investigator Site - Madrid

Madrid, 28034, Spain

Location

Investigator Site - Aberdeen

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Investigator Site - Manchester

Manchester, MD20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

etirinotecan pegol; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Nektar Therapeutics

medicalaffairs@nektar.com

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 5, 2009
• Study Start: December 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 12, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-07

Locations

US (9); ES (2); DE (2); GB (2); BE (1); IN (8)