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

Phase 2

Completed

• Conditions: Malignant Solid Tumor
• Interventions: Drug: NKTR-102 145 mg/m2; Drug: NKTR-102 120 mg/m2; Drug: NKTR-102 95 mg/m2; Drug: NKTR-102 50 mg/m2

• Registration Number: NCT01457118
• Lead Sponsor: Nektar Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2017-08
• Study Completion: 2017-11
• Results First Submitted: 2021-05-06
• Results First Submitted QC: 2021-06-14
• Status Verified: 2021-07
• Results First Posted: 2021-07-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NKTR-102	NKTR-102 50 mg/m2	-
NKTR-102	NKTR-102 120 mg/m2	-
NKTR-102	NKTR-102 95 mg/m2	-
NKTR-102	NKTR-102 145 mg/m2	-

Primary Outcome Measures

Name	Time	Method
Length of Exposure to NKTR-102	Screening, Every 21 day cycle of treatment and Quarterly Follow-up	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.

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Investigator Site - Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States

Investigator Site - Los Angeles; 🇺🇸 Los Angeles, California, United States

Investigator Site - Cleveland; 🇺🇸 Cleveland, Ohio, United States

Investigator Site - Whittier; 🇺🇸 Whittier, California, United States

Investigator Site - San Francisco; 🇺🇸 San Francisco, California, United States

Investigator Site - Liege; 🇧🇪 Liege, Belgium

Investigator Site - Bruxelles; 🇧🇪 Bruxelles, Belgium