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

NCT00806156 | Completed Phase 2 Results

• 1 other identifier: 08-PIR-04
• Study Type: interventional
• Target: 178
• Locations: 3 countries
• Sites: 20

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

Outcome Measures

Primary Outcomes (1)

• Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population

  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.

  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 Outcomes (27)

• 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)

• Secondary: Best Overall Response by GCIG Criteria: Prior PLD Therapy 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: Kaplan-Meier Estimate of Progression-Free Survival (PFS): 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)

Study Arms (2)

NKTR-102 q14d

EXPERIMENTAL

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.

Drug: NKTR-102 q14d

NKTR-102 q21d

EXPERIMENTAL

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.

Drug: NKTR-102 q21d

Interventions

NKTR-102 q14d DRUG

NKTR-102 given on a q14 day schedule

NKTR-102 q14d

NKTR-102 q21d DRUG

NKTR-102 given on a q21 day schedule

NKTR-102 q21d

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (20)

Investigator Site - Higland

Highland, California, 92346, United States

Location

Investigator Site - Los Angeles

Los Angeles, California, 90033, United States

Location

Investigator Site - Newport Beach

Newport Beach, California, 92663, United States

Location

Investigator Site - West Palm Beach

West Palm Beach, Florida, 33401, United States

Location

Investigator Site - Iowa City

Iowa City, Iowa, 52242, United States

Location

Investigator Site - Lansing

Lansing, Michigan, 48912, United States

Location

Investigator Site - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Investigator Site - Oklahoma City

Oklahoma City, Oklahoma, 73142, United States

Location

Investigator Site - East Providence

East Providence, Rhode Island, 02915, United States

Location

Investigator Site - Nashville

Nashville, Tennessee, 37203, United States

Location

Investigator Site - Charlottesville

Charlottesville, Virginia, 22908, United States

Location

Investigator Site - Gent

Ghent, Belgium

Location

Investigator Site - Leuven

Leuven, Belgium

Location

Investigator Site - Liege

Liège, Belgium

Location

Investigator Site - Wilrijk

Wilrijk, Belgium

Location

Investigator Site - Middlesex

Middlesex, Northwood, United Kingdom

Location

Investigator Site - Coventry

Coventry, United Kingdom

Location

Investigator Site - Dundee

Dundee, DD1 9SY, United Kingdom

Location

Investigator Site - Glasgow

Glasgow, G12 OYN, United Kingdom

Location

Investigator Site - Newcastle Upon Tyne

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28935273 DERIVED

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Study Director
• Organization: Nektar Therapeutics

medicalaffairs@nektar.com

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 10, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 12, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-07

Locations

US (11); GB (5); BE (4)