Basal-Like Breast CarcinomaPhase 1NCT00892736
Veliparib in Treating Patients With Malignant Solid Tumors That Do Not Respond to Previous Therapy
A Phase 1 study testing Laboratory Biomarker Analysis, Pharmacological Study and Veliparib in people with Basal-Like Breast Carcinoma and BRCA1 Mutation Carrier, run by National Cancer Institute (NCI) at 7 sites in United States.
Trial summary
This phase I trial studies the side effects and best dose of veliparib in treating patients with malignant solid tumors that do not respond to previous therapy. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Basal-Like Breast Carcinoma, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier
- What is being tested?
- Laboratory Biomarker Analysis, Pharmacological Study and Veliparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Apr 2009to 19 May 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed solid tumors that fulfill at least one of the following 3 criteria:
- Have a documented BRCA1/2 mutation and a BRCA related malignancy (primarily breast or ovarian cancers, but also may include prostate or pancreatic cancers); NOTE: Patients enrolled under the Dose Expansion Phase must have a documented BRCA 1/2 mutation; or
- Platinum-refractory ovarian, fallopian tube, or primary peritoneal cancer or
- Basal-like breast cancer whose disease has progressed following standard therapy or who have no acceptable standard treatment options
- All patients without a known, documented BRCA mutation from Myriad Genetic Laboratories must have a probability of harboring a BRCA gene mutation assessed by BRCAPRO computer program
- All patients in whom the probability of having a genetic mutation is >= 20% must have formal BRCA testing done through Myriad Genetic Laboratories in order to participate in the study
Show all 27Show fewer
- Although various research based tests have been developed to detect BRCA mutations, due to the fact that these are not Food and Drug Administration (FDA) or Clinical Laboratory Improvement Amendments (CLIA) approved and therefore not reportable to patients, if a patient has diagnosis of a BRAC mutation based on a non-Myriad test, then they must undergo Myriad BRCA gene sequencing to be eligible
- Patients are eligible whether they have a known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance
- If a patient refuses BRCA testing, then they are ineligible for the study
- Platinum-refractory is defined as progression or recurrence within 6 months of initial platinum response; platinum-resistant is defined as having no prior response to platinum (i.e. evidence of progression within 2-3 cycles of beginning initial platinum-based treatment) and platinum-resistant patients are excluded; the only platinum-sensitive patients that are eligible are those with known BRCA mutations
- Basal-like breast cancer will be defined as estrogen and progesterone receptor negative, human epidermal growth factor receptor 2 (HER2) negative, and/or having expression profile of epidermal growth factor receptor (EGFR) and cytokeratins 5/6, consistent with basal phenotype; breast cancer patients with "triple-negative" phenotype (negative hormone and HER2 receptors) are eligible to participate in this trial; patients who are only known to be "triple-negative" but unknown basal phenotype will have their tumor blocks assessed for basal markers
- For subjects enrolled under the Dose Escalation Phase: Enrolled patients without a known BRCA mutation must have archived tumor tissue available for assessment of BRCA 1/2 protein expression by immunohistochemistry, as well as other correlative studies; it is optional for patients with a known BRCA mutation to provide archived tissue for correlative studies
- For subjects enrolled under the Dose Expansion Phase: All patients enrolled during the Dose Expansion Phase (for which a tissue biopsy is mandatory) must have a known BRCA mutation and must agree to collection or archival tumor tissue, if available
- There are no limitations on the amount of prior therapies received; however, no major surgery, radiation or chemotherapy within four weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks; patients must be recovered from toxicities of prior therapies to at least eligibility levels
- Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%)
- Life expectancy of greater than 3 months
- Transaminases =< 2.5 times upper limit of normal (ULN)
- Bilirubin =< 2.0 mg/dL
- Creatinine =< ULN or a creatinine clearance > 50 ml/minute (calculated by Cockcroft-Gault formula) if creatinine > ULN
- Neutrophils >= 1500/uL
- Platelets >= 100,000/uL
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Ability to swallow pills
- Patients with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for > 3 months and must be off steroid treatment prior to study enrollment and must have a life expectancy of 3 months or greater to be eligible
- Patients with BRCA mutations who are enrolled in the 6-12 patient expansion group at dose level VIII (400 mg BID) must agree to tumor biopsies; therefore patients enrolled in this cohort should have tumors easily accessible for biopsies with low likelihood of complication and these patients should not be on therapeutic doses of anticoagulation
- Patients with BRCA mutations who are enrolled in the 6-12 patient expansion group at dose level VIII (400 mg BID) must agree to collection of archival tissue, if available; if not available, patient may still be enrolled as long as the patient consents to the mandatory fresh tumor tissue biopsies
Who cannot join
- Patients who have had chemotherapy, hormone therapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- Patients with prostate cancer must continue ongoing luteinizing-hormone-releasing hormone (LhRH) agonist therapy and discontinue antiandrogens at least 6 weeks (for bicalutamide) or 4 weeks (flutamide) prior to study entry; patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment
- Patients with CNS metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for > 3 months and must be off steroid treatment prior to study enrollment and must have a life expectancy secondary to that of 3 months or greater to be eligible
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV) infected patients on protease inhibitors are ineligible; HIV infected patients with adequate cluster of differentiation 4 (CD4) counts (> 500) and not on protease inhibitors are eligible
- Pregnant women are excluded; breastfeeding should be discontinued if the mother is treated with ABT-888
- Active seizure or history of seizure disorder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
City of Hope South Pasadena
South Pasadena, California, 91030
About this study
Official title: A Phase 1 Study of Chronically-Dosed, Single-Agent ABT-888 in Patients With Either BRCA 1/2 -Mutated Cancer; Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; or Basal-Like Breast Cancer
This phase I trial studies the side effects and best dose of veliparib in treating patients with malignant solid tumors that do not respond to previous therapy. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended phase II dose of chronically dosed single-agent ABT-888 (veliparib) in patients with either a refractory breast cancer (BRCA) 1/2- mutated solid cancer; platinum-refractory ovarian, fallopian tube, or primary peritoneal cancer; or basal-like breast cancer.
SECONDARY OBJECTIVES:
- To establish the safety and tolerability of single-agent ABT-888 in the above patient population. A dose expansion at the recommended phase II dose will be performed in 6-12 evaluable patients with germline BRCA mutations.
II. To determine the effects of ABT-888 treatment on the level of poly ADP-ribose polymerase (PARP) inhibition and deoxyribonucleic acid (DNA) damage in peripheral blood mononuclear cells (PBMCs) and tumor samples or cells in malignant ascitic fluid.
III. To determine the pharmacokinetics (PK) of chronically dosed ABT-888. IV. To document any evidence of anti-tumor response.
OUTLINE: This is a dose-escalation study.
Patients receive veliparib orally (PO) twice daily (BID)* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive veliparib once on day 1 of course 1 for pharmacokinetic and pharmacodynamic studies.
After completion of study therapy, patients are followed for 4 weeks.
- Conditions
- Basal-Like Breast Carcinoma, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Breast Carcinoma, Estrogen Receptor Negative, HER2/Neu Negative
- Being tested
- Laboratory Biomarker Analysis, Pharmacological Study, Veliparib
- Medical subject headings
- Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
VeliparibDrug
Also called ABT-888, PARP-1 inhibitor ABT-888
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (veliparib) | Experimental | Patients receive veliparib PO BID* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive veliparib once on day 1 of course 1 for pharmacokinetic and pharmacodynamic studies. Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Veliparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD, DLT, recommended phase II dose of chronically dosed single-agent veliparib in patients with either a refractory BRCA 1/2- mutated solid cancer; platinum- refractory ovarian, fallopian tube, or primary peritoneal cancer; or basal-like breast cancer
Measured: 28 days
Secondary outcomes (6)
Incidence of toxicities as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. All DLTs and other serious (grade 3 or greater) will be described on a patient-by-patient basis; descriptions will include dose level and any relevant baseline data. Statistics on the number of cycles received by patients and any dose reductions will be tabulated.
Measured: Up to 30 days post-treatment
Response (complete response, partial response, stable disease) evaluated using the Response Evaluation Criteria in Solid Tumors
Will be tabulated by disease diagnosis and by dose level.
Measured: Up to 4 weeks post-treatment
Pharmacokinetic parameters
Measured: Prior to taking veliparib on day 1, 4, and 15 then 30 minutes, 1 hour, 1½, 2, 3, 4, 6, and 8 hours after taking veliparib on day 1 and 15, and 24 hours after taking day 1 and day 15 doses of veliparib
Changes in PAR in PBMCs and tumor biopsies
Will be assessed with Wilcoxon signed rank tests.
Measured: Baseline to 4 weeks post-treatment
Changes in gamma-H2A histone family, member X (H2AX) in PBMCs and tumor biopsies
Will be assessed with Wilcoxon signed rank tests.
Measured: Baseline to 4 weeks post-treatment
Changes in BRCA 1/2 expression in tumor blocks
Comparisons of the expression levels in the two groups of patients will be made with Wilcoxon tests.
Measured: Baseline to 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study start20 Apr 2009
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal-Like Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shannon Puhalla, Principal investigator, University of Pittsburgh Cancer Institute (UPCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892736
- Sponsor's protocol ID
- NCI-2011-01472
- Other IDs
- NCI-2011-01472, CINJ-050810, CDR0000641433, UPCI # 08-121, UPCI 08-121, 8282, 8282, P30CA047904
- Status last verified
- Jun 2018
- First submitted
- 1 May 2009
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Chronically-Dosed, Single-Agent ABT-888 in Patients With Either BRCA 1/2 -Mutated Cancer; Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; or Basal-Like Breast Cancer
- ClinicalTrials.gov ID
- NCT00892736
- Acronym / sponsor ID
- NCI-2011-01472
- Conditions
- Basal-Like Breast Carcinoma, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Breast Carcinoma, Estrogen Receptor Negative, HER2/Neu Negative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 Apr 2009 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 4 May 2009 (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.
This phase I trial studies the side effects and best dose of veliparib in treating patients with malignant solid tumors that do not respond to previous therapy. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended phase II dose of chronically dosed single-agent ABT-888 (veliparib) in patients with either a refractory breast cancer (BRCA) 1/2- mutated solid cancer; platinum-refractory ovarian, fallopian tube, or primary peritoneal cancer; or basal-like breast cancer.
SECONDARY OBJECTIVES:
- To establish the safety and tolerability of single-agent ABT-888 in the above patient population. A dose expansion at the recommended phase II dose will be performed in 6-12 evaluable patients with germline BRCA mutations.
II. To determine the effects of ABT-888 treatment on the level of poly ADP-ribose polymerase (PARP) inhibition and deoxyribonucleic acid (DNA) damage in peripheral blood mononuclear cells (PBMCs) and tumor samples or cells in malignant ascitic fluid.
III. To determine the pharmacokinetics (PK) of chronically dosed ABT-888. IV. To document any evidence of anti-tumor response.
OUTLINE: This is a dose-escalation study.
Patients receive veliparib orally (PO) twice daily (BID)* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive veliparib once on day 1 of course 1 for pharmacokinetic and pharmacodynamic studies.
After completion of study therapy, patients are followed for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (veliparib) | Experimental | Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: VeliparibPatients receive veliparib PO BID* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients receive veliparib once on day 1 of course 1 for pharmacokinetic and pharmacodynamic studies. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients must have histologically or cytologically confirmed solid tumors that fulfill at least one of the following 3 criteria:
- All patients without a known, documented BRCA mutation from Myriad Genetic Laboratories must have a probability of harboring a BRCA gene mutation assessed by BRCAPRO computer program
- Platinum-refractory is defined as progression or recurrence within 6 months of initial platinum response; platinum-resistant is defined as having no prior response to platinum (i.e. evidence of progression within 2-3 cycles of beginning initial platinum-based treatment) and platinum-resistant patients are excluded; the only platinum-sensitive patients that are eligible are those with known BRCA mutations
- Basal-like breast cancer will be defined as estrogen and progesterone receptor negative, human epidermal growth factor receptor 2 (HER2) negative, and/or having expression profile of epidermal growth factor receptor (EGFR) and cytokeratins 5/6, consistent with basal phenotype; breast cancer patients with "triple-negative" phenotype (negative hormone and HER2 receptors) are eligible to participate in this trial; patients who are only known to be "triple-negative" but unknown basal phenotype will have their tumor blocks assessed for basal markers
- For subjects enrolled under the Dose Escalation Phase: Enrolled patients without a known BRCA mutation must have archived tumor tissue available for assessment of BRCA 1/2 protein expression by immunohistochemistry, as well as other correlative studies; it is optional for patients with a known BRCA mutation to provide archived tissue for correlative studies
Key exclusion criteria (8 listed)
- Patients who have had chemotherapy, hormone therapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- Patients with CNS metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for > 3 months and must be off steroid treatment prior to study enrollment and must have a life expectancy secondary to that of 3 months or greater to be eligible
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV) infected patients on protease inhibitors are ineligible; HIV infected patients with adequate cluster of differentiation 4 (CD4) counts (> 500) and not on protease inhibitors are eligible
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (veliparib) |
| Pharmacological StudyCorrelative studies | Other | Treatment (veliparib) |
| VeliparibAlso: ABT-888, PARP-1 inhibitor ABT-888Given PO | Drug | Treatment (veliparib) |
Primary outcome
MTD, DLT, recommended phase II dose of chronically dosed single-agent veliparib in patients with either a refractory BRCA 1/2- mutated solid cancer; platinum- refractory ovarian, fallopian tube, or primary peritoneal cancer; or basal-like breast cancer
Time frame: 28 days
6 secondary outcomes
Incidence of toxicities as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days post-treatment
Response (complete response, partial response, stable disease) evaluated using the Response Evaluation Criteria in Solid Tumors
Time frame: Up to 4 weeks post-treatment
Pharmacokinetic parameters
Time frame: Prior to taking veliparib on day 1, 4, and 15 then 30 minutes, 1 hour, 1½, 2, 3, 4, 6, and 8 hours after taking veliparib on day 1 and 15, and 24 hours after taking day 1 and day 15 doses of veliparib
Changes in PAR in PBMCs and tumor biopsies
Time frame: Baseline to 4 weeks post-treatment
Changes in gamma-H2A histone family, member X (H2AX) in PBMCs and tumor biopsies
Time frame: Baseline to 4 weeks post-treatment
Changes in BRCA 1/2 expression in tumor blocks
Time frame: Baseline to 4 weeks post-treatment
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 29 Jun 2018.
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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.
Shannon Puhalla principal investigator
University of Pittsburgh Cancer Institute (UPCI)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laboratory Biomarker Analysis, Pharmacological Study and Veliparib in people with Basal-Like Breast Carcinoma and BRCA1 Mutation Carrier, run by National Cancer Institute (NCI) at 7 sites in United States.
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 27 inclusion and 8 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
MTD, DLT, recommended phase II dose of chronically dosed single-agent veliparib in patients with either a refractory BRCA 1/2- mutated solid cancer; platinum- refractory ovarian, fallopian tube, or primary peritoneal cancer; or basal-like breast cancer (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2018.