NCT01457118

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 7, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

5.8 years

First QC Date

October 19, 2011

Results QC Date

May 6, 2021

Last Update Submit

July 9, 2021

Conditions

Malignant Solid Tumor

Keywords

Open Label multicenter extension study advanced solid tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Adverse Events

    Screening, Every 21 day cycle of treatment and Quarterly Follow-up

  • Disease Status

    Screening, Every 21 day cycle of treatment and Quarterly Follow-up

  • Efficacy of NKTR-102

    Screening, Every 21 day cycle of treatment and Quarterly Follow-up

Study Arms (1)

NKTR-102

EXPERIMENTAL
Drug: NKTR-102 145 mg/m2Drug: NKTR-102 120 mg/m2Drug: NKTR-102 95 mg/m2Drug: NKTR-102 50 mg/m2

Interventions

NKTR-102 145 mg/m2DRUG

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
NKTR-102 120 mg/m2DRUG

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
NKTR-102 95 mg/m2DRUG

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
NKTR-102 50 mg/m2DRUG

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

NKTR-102

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Investigator Site - Los Angeles

Los Angeles, California, 90033, United States

Location

Investigator Site - San Francisco

San Francisco, California, 94143, United States

Location

Investigator Site - Whittier

Whittier, California, 90603, United States

Location

Investigator Site - Minneapolis

Minneapolis, Minnesota, 55455, United States

Location

Investigator Site - Cleveland

Cleveland, Ohio, 44106, United States

Location

Investigator Site - Bruxelles

Brussels, Belgium

Location

Investigator Site - Liege

Liège, 4000, Belgium

Location

MeSH Terms

Interventions

etirinotecan pegol

Results Point of Contact

Title
Study Director
Organization
Nektar Therapeutics
medicalaffairs@nektar.com
415-482-5300

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

July 12, 2021

Results First Posted

July 7, 2021

Record last verified: 2021-07

Locations

US(5)BE(2)