Triple Negative Metastatic Breast CancerPhase 1NCT00516724
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
A Phase 1 study testing KU-0059436 (AZD2281)(PARP inhibitor), Carboplatin and Paclitaxel in people with Triple Negative Metastatic Breast Cancer and Advanced Ovarian Cancer, run by AstraZeneca at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Triple Negative Metastatic Breast Cancer, Advanced Ovarian Cancer, Carboplatin
- What is being tested?
- KU-0059436 (AZD2281)(PARP inhibitor), Carboplatin and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 22 Jun 2007to 11 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
Research Site
Amsterdam, 1066 EC
Research Site
Rotterdam, 3015
About this study
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
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.
- Conditions
- Triple Negative Metastatic Breast Cancer, Advanced Ovarian Cancer, Carboplatin, Paclitaxel
- Being tested
- KU-0059436 (AZD2281)(PARP inhibitor), Carboplatin, Paclitaxel, Paclitaxel + Carboplatin
- Keywords
- malignant solid tumours, Poly(ADP ribose) polymerases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KU-0059436 (AZD2281)(PARP inhibitor)Drug
Also called Olaparib
oral
CarboplatinDrug
Also called CBDCA, Paraplatin®
intravenous injection
KU-0059436 (AZD2281)(PARP inhibitor)Drug
Also called Olaparib
Oral
PaclitaxelDrug
Intravenous injection
KU-0059436 (AZD2281)(PARP inhibitor)Drug
Also called Olaparib
Oral
Paclitaxel + CarboplatinDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Carboplatin + KU-0059436 Receives: Drug: KU-0059436 (AZD2281)(PARP inhibitor); Drug: Carboplatin |
| 2. | Experimental | Paclitaxel + KU-0059436 Receives: Drug: KU-0059436 (AZD2281)(PARP inhibitor); Drug: Paclitaxel |
| 3. | Experimental | Paclitaxel, Carboplatin + KU-0059436 Receives: Drug: KU-0059436 (AZD2281)(PARP inhibitor); Drug: Paclitaxel + Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin
Measured: assessed at each visit
Secondary outcomes (1)
To identify the dose limiting toxicity of the combination therapy
Measured: assessed at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study start22 Jun 2007
- Primary completion4 Jan 2013
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jane Robertson, BSc, MBCHB, MD, Study director, AstraZenecaDr Johann de Bono, MD, Principal investigator, Cancer Research UK, The Institute of Cancer Research, London, UKProf Jan HM Schellens, Principal investigator, The Netherlands Cancer Institute, Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516724
- Sponsor's protocol ID
- KU36-96
- Other IDs
- D0810C00004, 2007-000939-26
- Status last verified
- Apr 2025
- First submitted
- 13 Aug 2007
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
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.
PubMed 31667659van 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.
PubMed 31637669Shamseddine 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.
PubMed 22248721
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00516724
- Acronym / sponsor ID
- KU36-96
- Conditions
- Triple Negative Metastatic Breast Cancer, Advanced Ovarian Cancer, Carboplatin, Paclitaxel
- Keywords
- malignant solid tumours, Poly(ADP ribose) polymerases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2007 (actual)
- Primary completion
- 4 Jan 2013 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: KU-0059436 (AZD2281)(PARP inhibitor), Drug: CarboplatinCarboplatin + KU-0059436 |
| 2. | Experimental | Drug: KU-0059436 (AZD2281)(PARP inhibitor), Drug: PaclitaxelPaclitaxel + KU-0059436 |
| 3. | Experimental | Drug: KU-0059436 (AZD2281)(PARP inhibitor), Drug: Paclitaxel + CarboplatinPaclitaxel, Carboplatin + KU-0059436 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KU-0059436 (AZD2281)(PARP inhibitor)Also: Olapariboral | Drug | 1 |
| CarboplatinAlso: CBDCA, Paraplatin®intravenous injection | Drug | 1 |
| KU-0059436 (AZD2281)(PARP inhibitor)Also: OlaparibOral | Drug | 2. |
| PaclitaxelIntravenous injection | Drug | 2. |
| KU-0059436 (AZD2281)(PARP inhibitor)Also: OlaparibOral | Drug | 3. |
| Paclitaxel + CarboplatinIntravenous injection | Drug | 3. |
Primary outcome
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin
Time frame: assessed at each visit
1 secondary outcome
To identify the dose limiting toxicity of the combination therapy
Time frame: assessed at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 31667659van 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.
- Derived from this study: PubMed 31637669van 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.
- Derived from this study: PubMed 22248721Shamseddine 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.
- KU36-96\_CSR\_SynopsisLink provided by the sponsor.
- revised\_CSP9Link provided by the sponsor.
- Study ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Related trials for Triple Negative Metastatic Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 2
A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
Triple-negative Breast Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Robertson, BSc, MBCHB, MD study director
AstraZeneca
Dr Johann de Bono, MD principal investigator
Cancer Research UK, The Institute of Cancer Research, London, UK
Prof Jan HM Schellens principal investigator
The Netherlands Cancer Institute, Amsterdam, The Netherlands
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KU-0059436 (AZD2281)(PARP inhibitor), Carboplatin and Paclitaxel in people with Triple Negative Metastatic Breast Cancer and Advanced Ovarian Cancer, run by AstraZeneca at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin (time frame: assessed at each visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516724, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.