Clinical trial NCT00516724: Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
Official title: A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Triple Negative Metastatic Breast Cancer
Advanced Ovarian Cancer
Carboplatin
Paclitaxel
Keywords: malignant solid tumours
Poly(ADP ribose) polymerases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Male or female patients with a histologically or cytologically diagnosed malignant solid tumour
* Adequate bone marrow, hepatic and renal function
* Performance status of no more than 2 ( ECOG scale).

Exclusion Criteria:

* Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
* Major surgery with 4 weeks of entering the study and must have recovered from effects of the major surgery
* More than two previous courses of platinum-containing chemotherapy
* Heavily pre-treated patients(\> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study

Primary outcomes:
measure: To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin
timeFrame: assessed at each visit
Secondary outcomes:
measure: To identify the dose limiting toxicity of the combination therapy
timeFrame: assessed at each visit
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson, BSc, MBCHB, MD
role: STUDY_DIRECTOR
affiliation: Cancer Research UK, The Institute of Cancer Research, London, UK
name: Dr Johann de Bono, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Netherlands Cancer Institute, Amsterdam, The Netherlands
name: Prof Jan HM Schellens
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Noll R, Jager A, Ang JE, Marchetti S, Mergui-Roelvink MWJ, Lolkema MP, de Jonge MJA, van der Biessen DA, Brunetto AT, Arkenau HT, Tchakov I, Beijnen JH, de Bono JS, Schellens JHM. Phase I study of continuous olaparib capsule dosing in combination with carboplatin and/or paclitaxel (Part 1). Invest New Drugs. 2020 Aug;38(4):1117-1128. doi: 10.1007/s10637-019-00856-7. Epub 2019 Oct 30.
citation: van der Noll R, Jager A, Ang JE, Marchetti S, Mergui-Roelvink MWJ, de Bono JS, Lolkema MP, de Jonge MJA, van der Biessen DA, Brunetto AT, Arkenau HT, Tchakov I, Beijnen JH, De Greve J, Schellens JHM. Phase I study of intermittent olaparib capsule or tablet dosing in combination with carboplatin and paclitaxel (part 2). Invest New Drugs. 2020 Aug;38(4):1096-1107. doi: 10.1007/s10637-019-00857-6. Epub 2019 Oct 21.
citation: Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10.