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Completed

NCT Number: NCT01457118

An Extension Study of NKTR-102 in Cancer Patients 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.

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Key information

Conditions

Malignant Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator Site - Bruxelles, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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

Exclusion:

  • 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

Treatment and study plan

NKTR-102 145 mg/m2

Drug

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

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. Length of Exposure to NKTR-102

    Time frame: 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 outcomes

  1. Adverse Events

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

    To evaluate the safety of continued exposure to NKTR-102.

  2. Disease Status

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

    To observe disease status and survival status in subjects receiving NKTR-102.

  3. Efficacy of NKTR-102

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2011
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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