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

Malignant Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457118
• Other study ID #: 11-PIR-09
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: November 2017

Study information

• Verified date: July 2021
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Tumor

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Investigator Site - Bruxelles	Bruxelles
Belgium	Investigator Site - Liege	Liege
United States	Investigator Site - Cleveland	Cleveland	Ohio
United States	Investigator Site - Los Angeles	Los Angeles	California
United States	Investigator Site - Minneapolis	Minneapolis	Minnesota
United States	Investigator Site - San Francisco	San Francisco	California
United States	Investigator Site - Whittier	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events	To evaluate the safety of continued exposure to NKTR-102.	Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Secondary	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
Secondary	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