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

NCT00802945 | Completed Phase 2 Results

• 1 other identifier: 08-PIR-05
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 19

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 breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting. Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 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. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.

Conditions

Tumor; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Up to 2 years.

Secondary Outcomes (5)

• Kaplan Meier Estimate of Progression-Free Survival (PFS)

  Up to 2 years.

• Kaplan Meier Estimate of Overall Survival (OS)

  Up to 2 years.

• Kaplan Meier Estimate of 6-month Survival

  From Cycle 1 Day 1 to the end of 6 months.

• Kaplan Meier Estimate of 1-year Survival

  From Cycle 1 Day 1 to the end of 12 months.

• Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group

  Up to 2 years.

Study Arms (2)

NKTR-102 q14d

EXPERIMENTAL

NKTR-102

Drug: NKTR-102

NKTR-102 q21d

EXPERIMENTAL

NKTR-102

Drug: NKTR-102

Interventions

NKTR-102 DRUG

NKTR-102 given on a q14 day schedule

NKTR-102 q14d

Eligibility Criteria

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

You may qualify if:

• Inoperable metastatic or locally advanced breast cancer
• No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
• Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (19)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089-9177, United States

Location

Desert Hematology Oncology Medical Group

Rancho Mirage, California, 92270, United States

Location

Stockton Hematology/Oncology

Stockton, California, 95204, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Louisville Oncology Clinical Research Program

Louisville, Kentucky, 40207, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Pharma Resource

East Providence, Rhode Island, 02915, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Institut Jules Bordet

Brussels, 2-2-541-72-26, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

De Pintelaan 1885

Ghent, 9000, Belgium

Location

CHU de Liege

Liège, 4000, Belgium

Location

GasthuisZusters Antwerpen

Wilrijk, 2610, Belgium

Location

Clatterbridge Centre for Oncology

Bebington, CH63 3J7, United Kingdom

Location

Velindre Hospital

Cardiff, CH14 2TL, United Kingdom

Location

Beatson Oncology Center

Glasgow, G12 ONY, United Kingdom

Location

St James University Hospital

Leed, LS97TF, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (1)

• Awada A, Garcia AA, Chan S, Jerusalem GH, Coleman RE, Huizing MT, Mehdi A, O'Reilly SM, Hamm JT, Barrett-Lee PJ, Cocquyt V, Sideras K, Young DE, Zhao C, Chia YL, Hoch U, Hannah AL, Perez EA; NKTR-102 Study Group. Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study. Lancet Oncol. 2013 Nov;14(12):1216-25. doi: 10.1016/S1470-2045(13)70429-7. Epub 2013 Oct 4.

  PMID: 24095299 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Interventions

etirinotecan pegol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Limitations of the trial such as small numbers of subjects analyzed or technical problems leading to unreliable data.

Results Point of Contact

• Title: Alison Hannah, MD
• Organization: Nektar

AHannah@nektar.com

Study Officials

• Alison Hannah, MD

  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 5, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 9, 2018
• Results First Posted: July 9, 2018

Record last verified: 2018-06

Locations

US (8); BE (5); GB (6)