Solid TumorsPhase 1NCT01617928
A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors
A Phase 1 study testing veliparib (ABT-888), carboplatin and paclitaxel in people with Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 1 site in Japan.
Trial summary
This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- veliparib (ABT-888), 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
- 12 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to Jul 2013
- 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
- Patients must have histologically or cytologically confirmed malignant solid tumor.
- Patients who are amenable to standard combination chemotherapy of carboplatin and paclitaxel.
- Patients should have received less than or equal to 1 prior chemotherapy regimens for advanced stage disease.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Patients must have normal organ and marrow function
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or the adverse events due to agents administered more than 3 weeks earlier have not recovered to less than grade 2.
- Known history of allergic reactions to carboplatin or cremophor-paclitaxel.
- Patients who have previously received a poly(ADP-ribose) polymerase (PARP) inhibitor.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection requiring treatment, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of seizure disorder.
- Hepatitis B surface antigen (HBsAg) positive, Hepatitis C virus (HCV) antibody positive or Human immunodeficiency virus (HIV)-positive patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors
This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.
- Conditions
- Solid Tumors
- Being tested
- veliparib (ABT-888), carboplatin, paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veliparib (ABT-888)Drug
Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort.
carboplatinDrug
Also called paraplatin
Carboplatin will be administered on Day 3 of each cycle, intravenously.
paclitaxelDrug
Also called taxol
Paclitaxel will be administered on Day 3 of each cycle, intravenously.
| Study group | Role | What they receive |
|---|---|---|
| veliparib (ABT-888) | Experimental | Not described Receives: Drug: veliparib (ABT-888); Drug: carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose and recommended Phase two dose
Measured: During the first cycle (21 days from first dose of veliparib)
Secondary outcomes (9)
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888)
Measured: Eight timepoints on Day 1 of first cycle (21 days)
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel
Measured: Eight timepoints on Day 3 of first cycle (21 days)
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of paclitaxel when administered in combination with veliparib (ABT-888) and carboplatin
Measured: Eight timepoints on Day 3 of first cycle (21 days)
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of carboplatin when administered in combination with veliparib (ABT-888) and paclitaxel
Measured: Six timepoints on Day 3 of first cycle (21 days)
Preliminary tumor response
Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
Measured: From date of first dose of veliparib until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 6 cycles.
Safety assessment; Physical exam including vital signs
Blood pressure, pulse and body temperature
Measured: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Safety assessment; Clinical lab testings
Hematology, Chemistry and Urinalysis
Measured: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Safety assessment; Adverse event monitoring
Collect all adverse events at each visit
Measured: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Safety assessment; Change from Baseline in Electrocardiogram (ECG)
Measured: Day 8 of first cycle (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
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 Solid TumorsStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideyuki Hashiba, BS, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617928
- Sponsor's protocol ID
- M12-629
- Status last verified
- Jul 2013
- First submitted
- 23 May 2012
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mizugaki H, Yamamoto N, Nokihara H, Fujiwara Y, Horinouchi H, Kanda S, Kitazono S, Yagishita S, Xiong H, Qian J, Hashiba H, Shepherd SP, Giranda V, Tamura T. A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2015 Nov;76(5):1063-72. doi: 10.1007/s00280-015-2876-7. Epub 2015 Oct 3.
PubMed 26433581
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01617928
- Acronym / sponsor ID
- M12-629
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Jun 2012 (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 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.
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), Drug: carboplatin, Drug: paclitaxel |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have histologically or cytologically confirmed malignant solid tumor.
- Patients who are amenable to standard combination chemotherapy of carboplatin and paclitaxel.
- Patients should have received less than or equal to 1 prior chemotherapy regimens for advanced stage disease.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Patients must have normal organ and marrow function
Key exclusion criteria (6 listed)
- Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or the adverse events due to agents administered more than 3 weeks earlier have not recovered to less than grade 2.
- Known history of allergic reactions to carboplatin or cremophor-paclitaxel.
- Patients who have previously received a poly(ADP-ribose) polymerase (PARP) inhibitor.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection requiring treatment, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of seizure disorder.
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)Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort. | Drug | veliparib (ABT-888) |
| carboplatinAlso: paraplatinCarboplatin will be administered on Day 3 of each cycle, intravenously. | Drug | veliparib (ABT-888) |
| paclitaxelAlso: taxolPaclitaxel will be administered on Day 3 of each cycle, intravenously. | Drug | veliparib (ABT-888) |
Primary outcome
Determine the maximum tolerated dose and recommended Phase two dose
Time frame: During the first cycle (21 days from first dose of veliparib)
9 secondary outcomes
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888)
Time frame: Eight timepoints on Day 1 of first cycle (21 days)
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel
Time frame: Eight timepoints on Day 3 of first cycle (21 days)
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of paclitaxel when administered in combination with veliparib (ABT-888) and carboplatin
Time frame: Eight timepoints on Day 3 of first cycle (21 days)
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of carboplatin when administered in combination with veliparib (ABT-888) and paclitaxel
Time frame: Six timepoints on Day 3 of first cycle (21 days)
Preliminary tumor response
Time frame: From date of first dose of veliparib until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 6 cycles.
Safety assessment; Physical exam including vital signs
Time frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Safety assessment; Clinical lab testings
Time frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Safety assessment; Adverse event monitoring
Time frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Safety assessment; Change from Baseline in Electrocardiogram (ECG)
Time frame: Day 8 of first cycle (21 days)
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 20 Nov 2017.
- Results publication: PubMed 26433581Mizugaki H, Yamamoto N, Nokihara H, Fujiwara Y, Horinouchi H, Kanda S, Kitazono S, Yagishita S, Xiong H, Qian J, Hashiba H, Shepherd SP, Giranda V, Tamura T. A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2015 Nov;76(5):1063-72. doi: 10.1007/s00280-015-2876-7. Epub 2015 Oct 3.
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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
1 site 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), carboplatin and paclitaxel in people with Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 1 site 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 5 inclusion and 6 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Determine the maximum tolerated dose and recommended Phase two dose (time frame: During the first cycle (21 days from first dose of veliparib)). 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 NCT01617928, 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 20 Nov 2017.