An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies

An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.

In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Tumor
• Intervention / Treatment: Drug: NKTR-102 145 mg/m2; Drug: NKTR-102 120 mg/m2; Drug: NKTR-102 95 mg/m2; Drug: NKTR-102 50 mg/m2

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Investigator Site - Bruxelles
  • Liege, Belgium, 4000
    • Investigator Site - Liege
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Investigator Site - Los Angeles
    • San Francisco, California, United States, 94143
      • Investigator Site - San Francisco
    • Whittier, California, United States, 90603
      • Investigator Site - Whittier
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Investigator Site - Minneapolis
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Investigator Site - Cleveland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

1. Received prior treatment with NKTR-102
2. Free of disease progression since receiving NKTR-102
3. Adequate bone marrow and organ function
4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
5. Agree to use adequate contraception

Exclusion:

1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose < 70 mg/m2 upon entry into this study
3. Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NKTR-102

Drug: NKTR-102 145 mg/m2; A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; Drug: NKTR-102 120 mg/m2; A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; Drug: NKTR-102 95 mg/m2; A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; Drug: NKTR-102 50 mg/m2; A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Exposure to NKTR-102	To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.	Screening, Every 21 day cycle of treatment and Quarterly Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	To evaluate the safety of continued exposure to NKTR-102.	Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Disease Status	To observe disease status and survival status in subjects receiving NKTR-102.	Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Efficacy of NKTR-102	To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.	Screening, Every 21 day cycle of treatment and Quarterly Follow-up

Collaborators and Investigators

• Sponsor: Nektar Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Open Label multicenter extension study advanced solid tumors
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etirinotecan pegol
• Other Study ID Numbers: 11-PIR-09