Clinical trial NCT00494442: Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
Official title: A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasm
Keywords: Advanced ovarian cancer
Poly(ADP ribose) polymerases
KU-0059436
AZD2281
BRCA1 protein
BRCA2 protein
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: KuDOS Pharmaceuticals Limited
First posted: 2007-06-29
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Eligibility criteria: Inclusion Criteria:

* Advanced ovarian cancer with positive BRCA1 or BRCA2 status
* Failed at least one prior chemotherapy
* In investigators opinion, no curative standard therapy exists
* Measurable disease

Exclusion Criteria:

* Brain metastases
* Less than 28 days since last treatment used to treat the disease
* Considered a poor medical risk due to a serious uncontrolled disorder

Primary outcomes:
measure: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)
timeFrame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.
Secondary outcomes:
measure: Clinical Benefit (CB)
timeFrame: End of study
measure: Duration of Response
timeFrame: End of study
measure: Best Percentage Change in Tumour Size
timeFrame: End of study
measure: Progression-Free Survival (PFS)
timeFrame: End of study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: New York
country: United States
facility: Research Site
state: New York
city: Houston
country: United States
facility: Research Site
state: Texas
city: Melbourne, Parkville
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Randwick
country: Australia
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Hospitalet deLlobregat
country: Spain
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: KuDOS Pharmaceuticals Limited
name: James Carmichael, BSc MBChB MD FRCP
role: STUDY_DIRECTOR
affiliation: Guy's and St Thomas's NHS Foundation Trust, London, UK
name: Andrew Tutt, PhD MRCP FRCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.
citation: Ang JE, Gourley C, Powell CB, High H, Shapira-Frommer R, Castonguay V, De Greve J, Atkinson T, Yap TA, Sandhu S, Banerjee S, Chen LM, Friedlander ML, Kaufman B, Oza AM, Matulonis U, Barber LJ, Kozarewa I, Fenwick K, Assiotis I, Campbell J, Chen L, de Bono JS, Gore ME, Lord CJ, Ashworth A, Kaye SB. Efficacy of chemotherapy in BRCA1/2 mutation carrier ovarian cancer in the setting of PARP inhibitor resistance: a multi-institutional study. Clin Cancer Res. 2013 Oct 1;19(19):5485-93. doi: 10.1158/1078-0432.CCR-13-1262. Epub 2013 Aug 6.
citation: Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, Weitzel JN, Oaknin A, Loman N, Lu K, Schmutzler RK, Matulonis U, Wickens M, Tutt A. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):245-51. doi: 10.1016/S0140-6736(10)60893-8. Epub 2010 Jul 6.