Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer

NCT ID: NCT00806156

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-01-31

Brief 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.

Conditions

Tumor; Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NKTR-102 q14d

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.

Group Type: EXPERIMENTAL

NKTR-102 q14d

Intervention Type: DRUG

NKTR-102 given on a q14 day schedule

NKTR-102 q21d

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.

Group Type: EXPERIMENTAL

NKTR-102 q21d

Intervention Type: DRUG

NKTR-102 given on a q21 day schedule

Interventions

NKTR-102 q14d

NKTR-102 given on a q14 day schedule

Intervention Type: DRUG

NKTR-102 q21d

NKTR-102 given on a q21 day schedule

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nektar Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Nektar Therapeutics

Locations

Investigator Site - Higland

Highland, California, United States

Investigator Site - Los Angeles

Los Angeles, California, United States

Investigator Site - Newport Beach

Newport Beach, California, United States

Investigator Site - West Palm Beach

West Palm Beach, Florida, United States

Investigator Site - Iowa City

Iowa City, Iowa, United States

Investigator Site - Lansing

Lansing, Michigan, United States

Investigator Site - Winston-Salem

Winston-Salem, North Carolina, United States

Investigator Site - Oklahoma City

Oklahoma City, Oklahoma, United States

Investigator Site - East Providence

East Providence, Rhode Island, United States

Investigator Site - Nashville

Nashville, Tennessee, United States

Investigator Site - Charlottesville

Charlottesville, Virginia, United States

Investigator Site - Gent

Ghent, , Belgium

Investigator Site - Leuven

Leuven, , Belgium

Investigator Site - Liege

Liège, , Belgium

Investigator Site - Wilrijk

Wilrijk, , Belgium

Investigator Site - Middlesex

Middlesex, Northwood, United Kingdom

Investigator Site - Coventry

Coventry, , United Kingdom

Investigator Site - Dundee

Dundee, , United Kingdom

Investigator Site - Glasgow

Glasgow, , United Kingdom

Investigator Site - Newcastle Upon Tyne

Newcastle upon Tyne, , United Kingdom

Countries

United States; Belgium; United Kingdom

References

Rustin 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.

Reference Type: DERIVED

PMID: 28935273 (View on PubMed)

Other Identifiers

08-PIR-04

Identifier Type: -

Identifier Source: org_study_id