Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

Conditions

Triple Negative Metastatic Breast Cancer, Advanced Ovarian Cancer, Carboplatin, Paclitaxel

Keywords

malignant solid tumours, Poly(ADP ribose) polymerases

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.

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.

2019-10-3014 citations

10.1007/s10637-019-00856-7

Phase I study of intermittent olaparib capsule or tablet dosing in combination with carboplatin and paclitaxel (part 2).

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 Grève J, Schellens JHM.

2019-10-2115 citations

10.1007/s10637-019-00857-6

A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1- or BRCA2-mutated HER2-negative advanced breast cancer as first line treatment (REVIVAL): study protocol for a randomized controlled trial

Philip C. Schouten, Gwen Dackus, Serena Marchetti, Harm van Tinteren, Gabe S. Sonke et al. (7 authors)

Trials2016-06-2118 citations

10.1186/s13063-016-1423-0

Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first- or second-line treatment of patients with metastatic triple-negative breast cancer.

Dent RA, Lindeman GJ, Clemons M, Wildiers H, Chan A, McCarthy NJ, Singer CF, Lowe ES, Watkins CL, Carmichael J.

2013-01-01140 citations

10.1186/bcr3484

Interventions

DRUGPaclitaxel + Carboplatin

Intravenous injection

DRUGKU-0059436 (AZD2281)(PARP inhibitor)

oral

DRUGCarboplatin

intravenous injection

DRUGPaclitaxel

Intravenous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin	assessed at each visit

Secondary

Measure	Time frame
To identify the dose limiting toxicity of the combination therapy	assessed at each visit

Countries

Belgium, Netherlands, United Kingdom

Outcome results

None listed