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NKTR-102, a next-generation topoisomerase I inhibitor, has been granted orphan drug status by the FDA for the treatment of women with ovarian cancer, according to Nektar Therapeutics, the San Francisco, California, company developing the drug.
Nektar made the announcement April 21 amid an ongoing phase II study of the effectiveness of NKTR- 102 in patients with platinum-resistant ovarian cancer and disease progression after pegylated liposomal doxorubicin therapy. Investigators are seeking to enroll 125 participants in that study, and plans also are underway for a phase III study.
Last year, promising phase I data presented at the American Society of Clinical Oncology annual meeting indicated that NKTR-102 demonstrated signifi cant antitumor activity, with a confi rmed response rate of 11% in patients with refractory solid tumors.
Nektar describes NKTR-102 as having a unique profi le that uses a releasable polymer conjugate technology platform the company invented. NKTR- 102 appears to function as an improved form of the chemotherapeutic agent irinotecan, allowing the active drug to be maintained at a continuous concentration instead of clearing from the body within a few hours of dosing, as the standard therapy version does.
In addition to ovarian cancer, Nektar is investigating NKTR-102 for patients with metastatic breast cancer, and as second-line and combination therapy for patients with colorectal cancer.
The orphan drug designation, aimed at promoting the development of medicines for diseases that affect fewer than 200,000 people, grants a company US market exclusivity for 7 years.
STUDY TYPE: Interventional
AGE/SEX REQUIREMENTS: Women ≥18 years of age who have breast, ovarian, uterine, or cervical cancers that have not responded to standard treatment. Men ≥18 years of age who have metastatic breast cancer and a BRCA1/2 mutation.
SPONSOR: National Cancer Institute
CLINICALTRIALS.GOV IDENTIFIER: NCT01237067
PURPOSE: The objective of this study is to determine the safety and effectiveness of combined carboplatin and olaparib as a treatment for gynecologic or breast cancer. The trial will determine a safe dose of olaparib tablet with carboplatin, estimate the pharmacokinetic and pharmacodynamic effects of 2 schedules of olaparib and carboplatin by using peripheral blood mononuclear cells, and determine the schedule-associated safety of olaparib and carboplatin in women’s cancers.
EXPIRES:February 12, 2012 This activity is intended for oncologists, surgeons, pathologists, obstetrician/gynecologists, nurses, and other healthcare professionals who screen, diagnose, and treat women with breast cancer. The goals of this activity are to review the epidemiology and diagnosis of triple-negative breast cancer (TNBC) and to review current as well as any new and novel treatments. Another goal is to identify practice changes based on key developments that may help to improve quality of life and outcomes in patients with TNBC. Also discussed are screening practices, surgery, and epidemiology of TNBC.