Phase 2
Completed N=178
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
Source: ClinicalTrials.gov NCT00806156 ↗Enrolled (actual)
178
Serious AEs
57.1%
Results posted
Jun 2021
Primary outcomePrimary: Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population — 14.4; 14.4 Percentage of Patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population |
14.4; 14.4 | — |
| SECONDARY Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population |
29.7; 25; 26 | — |
| SECONDARY Secondary: Best Overall Response by GCIG Criteria: Primary Efficacy Population |
25; 25 | — |
| SECONDARY Secondary: Best Overall Response by GCIG Criteria: Platinum-Refractory Population |
23.1; 17.3; 18.5 | — |
| SECONDARY Secondary: Best Overall Response by GCIG Criteria: Prior PLD Therapy Population |
25; 24.6; 24.6 | — |
| SECONDARY Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS): MITT Population |
4.1; 4.4; 4.4 | — |
| SECONDARY Secondary: Kaplan-Meier Estimate of PFS: Primary Efficacy Population |
4.4; 4.4 | — |
| SECONDARY Secondary: Kaplan-Meier Estimate of PFS: Platinum-Refractory Population |
11.9; 2.7; 3 | — |
| SECONDARY Secondary: Kaplan-Meier Estimate of PFS: Prior PLD Therapy Population |
5.5; 4.4; 4.5 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of Duration of Overall Response (DoR): MITT Population |
4.1; 6.6; 5.7 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of DoR: Primary Efficacy Population |
7.4; 7.4 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of DoR: Platinum-Refractory Population |
10.8; 7.4; 7.4 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of DoR: Prior PLD Therapy Population |
4.2; 7.4; 6.6 | — |
| SECONDARY Secondary: CA-125 Response Rate: MITT Population |
43.8; 34.9; 36.9 | — |
| SECONDARY Secondary: CA-125 Response Rate: Primary Efficacy Population |
33; 33 | — |
| SECONDARY Secondary: CA-125 Response Rate: Platinum-Refractory Population |
36.4; 20; 23.5 | — |
| SECONDARY Secondary: CA-125 Response Rate: Prior PLD Therapy Population |
40; 33.7; 34.5 | — |
| SECONDARY Secondary: Clinical Benefit Rate: MITT Population |
56.8; 50.8; 52.1 | — |
| SECONDARY Secondary: Clinical Benefit Rate: Primary Efficacy Population |
51; 51 | — |
| SECONDARY Secondary: Clinical Benefit Rate: Platinum-Refractory Population |
61.5; 38.5; 43.1 | — |
| SECONDARY Secondary: Clinical Benefit Rate: Prior PLD Therapy Population |
56.3; 50.9; 51.5 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of Overall Survival (OS): MITT Population |
11.1; 10.2; 10.6 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of OS: Primary Efficacy Population |
10.9; 10.9 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of OS: Platinum-Refractory Population |
11.1; 8; 9.4 | — |
| SECONDARY Secondary: Kaplan-Meier Analysis of OS: Prior PLD Therapy Population |
12.2; 11; 11 | — |
| SECONDARY Secondary: ORR by RECIST: MITT Population |
21.6; 15.2; 16.6 | — |
| SECONDARY Secondary: ORR by RECIST: Prior PLD Population |
18.8; 14.9; 15.4 | — |
| SECONDARY Secondary: ORR by RECIST: Platinum-Refractory Population |
15.4; 15.4; 15.4 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
- Inoperable metastatic or locally advanced ovarian cancer
- Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of last dose of most recent platinum drug
- 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.
- Diseases must be measurable as defined by RECIST in at least 1 lesion not previously irradiated.
- ECOG performance score of 0 or 1.
- Adequate organ and bone marrow functions at Screening.
Exclusion Criteria
- 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
- 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
- Patients who have received CYP3A4 inducers or inhibitors.
- Patients who have received any treatment with a camptothecin derivative (eg. irinotecan, topotecan, SN38 investigational agents, etc.).
- Patients with CNS metastases.
Data sourced from ClinicalTrials.gov (NCT00806156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.