Clinical trial · Interventional
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Platinum-Resistant Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer. Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/m\^2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NKTR-102 q14d | Drug | — | UNRESOLVED |
| NKTR-102 q21d | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NKTR-102 q14d
- description
- NKTR-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.
- interventionNames
- Drug: NKTR-102 q14d
- type
- EXPERIMENTAL
- label
- NKTR-102 q21d
- description
- NKTR-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.
- interventionNames
- Drug: NKTR-102 q21d
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 months of last dose of most recent platinum drug 4. Platinum-resistant patients who have progressed after receiving PLD (Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to receive PLD therapy. 5. Diseases must be measurable as defined by RECIST in at least 1 lesion not previously irradiated. 6. ECOG performance score of 0 or 1. 7. Adequate organ and bone marrow functions at Screening. Exclusion Criteria: 1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity prior to Day 1 of Cycle 1 2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 of Cycle 1 3. Patients who have received CYP3A4 inducers or inhibitors. 4. Patients who have received any treatment with a camptothecin derivative (eg. irinotecan, topotecan, SN38 investigational agents, etc.). 5. Patients with CNS metastases.
References
Publications (1)
- DERIVEDRustin G, Vergote I, Micha JP, Duska LR, Reed N, Bendell J, Spitz D, Dark G, Hoch U, Tagliaferri M, Hannah AL, Garcia AA. A multicenter, open-label, expanded phase 2 study to evaluate the safety and efficacy of etirinotecan pegol, a polymer conjugate of irinotecan, in women with recurrent platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2017 Nov;147(2):276-282. doi: 10.1016/j.ygyno.2017.08.026. Epub 2017 Sep 19. PMID 28935273