Advanced Solid TumorsPhase 1NCT02210663
A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
A Phase 1 study testing veliparib (ABT-888) in people with Advanced Solid Tumors, run by AbbVie at 3 sites in Japan.
Trial summary
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- veliparib (ABT-888)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2014to Jul 2016
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed malignant solid tumor, and any of the following: * Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; * Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; * Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy of greater than 12 weeks.
- Adequate organ and marrow function· Measurable or non-measurable disease.
Who cannot join
- Major surgery and/or radiation within (<) 4 weeks prior to study enrollment.
- Chemotherapy or hormone therapy within (<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks.
- Any investigational agents within (<) 4 weeks prior to study enrollment.
- Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
- Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Site Reference ID/Investigator# 128056
Hidaka-shi
Site Reference ID/Investigator# 129976
Hyōgo
Site Reference ID/Investigator# 128057
Tokyo
About this study
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- veliparib (ABT-888)
- Keywords
- Breast cancer, PARP, Primary peritoneal cancer, Fallopian tube, Ovarian cancer, veliparib, ABT-888, BRCA
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veliparib (ABT-888)Drug
Also called veliparib, ABT-888
Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.
| Study group | Role | What they receive |
|---|---|---|
| veliparib (ABT-888) | Experimental | Not described Receives: Drug: veliparib (ABT-888) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities of veliparib
Measured: During the first cycle (28 days) of veliparib administration
Secondary outcomes (7)
Change in participant physical exam measurements
Blood pressure, pulse and body temperature
Measured: Approximately 1 year
Change in participant clinical lab results
Hematology, Chemistry and Urinalysis
Measured: Approximately 1 year
Number of participants with adverse events
Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Measured: Approximately 1 year
Preliminary tumor response
According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Measured: Participants will be followed for the duration of an expected average of 8 months.
Maximum observed plasma concentration (Cmax)
Maximum observed concentration, occurring at Tmax
Measured: For 24 hours following veliparib dosing.
The time to Cmax (peak time, Tmax)
The time at which maximum plasma concentration (Cmax) is observed.
Measured: For 24 hours following veliparib dosing.
The area under the plasma concentration-time curve (AUC)
Measured: For 24 hours following veliparib dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideyuki Hashiba, BS, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210663
- Sponsor's protocol ID
- M14-489
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2014
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.
PubMed 28665051
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02210663
- Acronym / sponsor ID
- M14-489
- Conditions
- Advanced Solid Tumors
- Keywords
- Breast cancer, PARP, Primary peritoneal cancer, Fallopian tube, Ovarian cancer, veliparib, ABT-888, BRCA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Aug 2014 (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 is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| veliparib (ABT-888) | Experimental | Drug: veliparib (ABT-888) |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed malignant solid tumor, and any of the following: * Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; * Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; * Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy of greater than 12 weeks.
- Adequate organ and marrow function· Measurable or non-measurable disease.
Key exclusion criteria (5 listed)
- Major surgery and/or radiation within (<) 4 weeks prior to study enrollment.
- Chemotherapy or hormone therapy within (<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks.
- Any investigational agents within (<) 4 weeks prior to study enrollment.
- Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
- Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.
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 |
|---|---|---|
| veliparib (ABT-888)Also: veliparib, ABT-888Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally. | Drug | veliparib (ABT-888) |
Primary outcome
Dose-limiting toxicities of veliparib
Time frame: During the first cycle (28 days) of veliparib administration
7 secondary outcomes
Change in participant physical exam measurements
Time frame: Approximately 1 year
Change in participant clinical lab results
Time frame: Approximately 1 year
Number of participants with adverse events
Time frame: Approximately 1 year
Preliminary tumor response
Time frame: Participants will be followed for the duration of an expected average of 8 months.
Maximum observed plasma concentration (Cmax)
Time frame: For 24 hours following veliparib dosing.
The time to Cmax (peak time, Tmax)
Time frame: For 24 hours following veliparib dosing.
The area under the plasma concentration-time curve (AUC)
Time frame: For 24 hours following veliparib dosing.
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 7 May 2018.
- Results publication: PubMed 28665051Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.
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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.
Hideyuki Hashiba, BS study director
AbbVie
3 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 veliparib (ABT-888) in people with Advanced Solid Tumors, run by AbbVie at 3 sites in Japan.
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 4 inclusion and 5 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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?
Dose-limiting toxicities of veliparib (time frame: During the first cycle (28 days) of veliparib administration). 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 NCT02210663, which also lists 1 linked publication.
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 7 May 2018.