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NKTR-102/m2

Phase 2

Malignant Solid Tumor | Small molecule | Oncology |Nektar Therapeutics|Last Updated: Jul 12, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

NKTR-102/m2 · 1 trial · 1 indication

Phase 2 1
NCT01457118An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 StudiesMalignant Solid Tumor
COMPLETED27 Analytics
PHASE2COMPLETED
An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
Malignant Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NKTR-102EXPERIMENTAL -

Interventions

NameTypeDescription
NKTR-102 145 mg/m2DRUGA 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/m2DRUGA 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/m2DRUGA 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/m2DRUGA 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

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 ...

Countries:United StatesBelgium
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Frequently asked questions about NKTR-102/m2

What is NKTR-102 used for?

NKTR-102, also known as etirinotecan pegol, is an investigational small molecule being studied for the treatment of advanced cancer, tumors, metastasis, malignant solid tumors, locally recurrent breast cancer, and colorectal cancer. It is in clinical development for oncology indications, including metastatic breast cancer.

What does NKTR-102 target?

NKTR-102 is a topoisomerase I inhibitor that works by targeting the enzyme topoisomerase I, which is involved in DNA replication. By inhibiting this enzyme, it is designed to interfere with cancer cell growth and division.

Who makes NKTR-102?

NKTR-102 is being developed by Nektar Therapeutics, a biopharmaceutical company. Nektar Therapeutics is publicly traded under the ticker symbol NKTR on the NASDAQ stock exchange.

What phase is NKTR-102 in?

NKTR-102 has completed Phase 1, Phase 2, and Phase 3 clinical trials. It is an investigational drug and has not been approved by the FDA. The completed trials include a Phase 3 study in breast cancer and a Phase 1 study in advanced cancer.

What clinical trials is NKTR-102 in?

NKTR-102 has been studied in several clinical trials, including NCT01457118, an extension study in cancer patients; NCT01492101, the BEACON study in breast cancer; NCT01976143, a Phase 1 study evaluating its effect on QTc interval; and NCT02915744, a Phase 3 study in metastatic breast cancer with brain metastases.

Is NKTR-102 the same as etirinotecan pegol?

Yes, NKTR-102 is also known as etirinotecan pegol. The drug is referred to by both names in clinical trial records and medical literature.