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NKTR-102 q14d

Phase 2

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

RandomizedCONTROLLED
Total Trials1
Total Enrollment178

FDA Designations

No designations recorded

Clinical trial landscape

NKTR-102 q14d · 1 trial · 2 indications

Phase 2 1
NCT00806156Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian CancerTumor
COMPLETED178 Analytics
PHASE2COMPLETED
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population
Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.

Secondary Endpoints

Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population
Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)
Secondary: Best Overall Response by GCIG Criteria: Primary Efficacy Population
Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)
Secondary: Best Overall Response by GCIG Criteria: Platinum-Refractory Population
Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NKTR-102 q14dEXPERIMENTALNKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
NKTR-102 q21dEXPERIMENTALNKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.

Interventions

NameTypeDescription
NKTR-102 q14dDRUGNKTR-102 given on a q14 day schedule
NKTR-102 q21dDRUGNKTR-102 given on a q21 day schedule
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer 2. Inoperable metastatic or locally advanced ovarian cancer 3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 mont...

Countries:United StatesBelgiumUnited Kingdom
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Frequently asked questions about NKTR-102 q14d

What is NKTR-102 q14d used for?

NKTR-102 q14d is an investigational small molecule being studied for the treatment of tumors, specifically metastatic or locally advanced ovarian cancer. It is administered on a 14-day schedule. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes NKTR-102 q14d?

NKTR-102 q14d is being developed by Nektar Therapeutics, a biopharmaceutical company traded on the NASDAQ under the ticker symbol NKTR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.

What phase is NKTR-102 q14d in?

NKTR-102 q14d is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for its potential use in treating patients with metastatic or locally advanced ovarian cancer.

What clinical trials is NKTR-102 q14d in?

NKTR-102 q14d has been studied in one completed Phase 2 clinical trial, identified as NCT00806156. This trial evaluated the safety and efficacy of the drug in 178 female patients with metastatic or locally advanced ovarian cancer. The study was conducted in the United States, Belgium, and the United Kingdom.

How does NKTR-102 q14d work?

NKTR-102 q14d is a small molecule oncology drug. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its ability to treat tumors, particularly ovarian cancer, through a mechanism that is the subject of ongoing clinical investigation.