Solid TumorsPhase 1NCT01199224
To Determine the Food Effect and Bioavailability of Three Formulations of Veliparib in Subjects With Solid Tumors
A Phase 1 study testing veliparib in people with Solid Tumors, run by AbbVie.
Trial summary
Compare the bioavailability of three veliparib formulations in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- veliparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Nov 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy.
- In the opinion of the Investigator, life expectancy is 12 weeks or greater.
- Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.
Who cannot join
- The subject is unable to swallow capsules or has nausea or vomiting.
- Female subject is pregnant or breast-feeding.
- Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome).
- History of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (pH) or absorption.
- Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Known seizure disorder that is uncontrolled over the past month
Show all 9Show fewer
- Active uncontrolled infection
- Unstable angina pectoris or cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
About this study
Official title: A Phase 1, Single-Dose, Randomized, Group Sequential Cross-Over Study Evaluating the Bioavailability and Food Effect of Three Formulations of Veliparib on Pharmacokinetics in Subjects With Solid Tumors
Compare the bioavailability of three veliparib formulations in subjects with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- veliparib
- Keywords
- Solid Tumors, veliparib, refractory, relapsed
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veliparibDrug
Also called ABT-888
veliparib formulation A
veliparibDrug
Also called ABT-888
veliparib formulation B
veliparibDrug
Also called ABT-888
veliparib formulation C
veliparibDrug
Also called ABT-888, velaparib
veliparib formulation C
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: veliparib |
| Arm B | Experimental | Not described Receives: Drug: veliparib |
| Arm C | Experimental | Not described Receives: Drug: veliparib |
| Arm D | Experimental | Not described Receives: Drug: veliparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the oral bioavailability of veliparib
Assess the relative bioavailability of Formulation A, Formulation B and Formulation C with or without food measured using area under the plasma concentration-time curve (AUC), the maximum observed plasma concentration (Cmax), and time to Cmax (Tmax).
Measured: Up to 4 weeks.
Secondary outcomes (1)
To evaluate the safety and tolerability of veliparib in patients with solid tumors
Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionNov 2010
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhardwaj Desai, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199224
- Sponsor's protocol ID
- M11-846
- Status last verified
- Dec 2010
- First submitted
- 19 Jul 2010
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mostafa NM, Chiu YL, Rosen LS, Bessudo A, Kovacs X, Giranda VL. A phase 1 study to evaluate effect of food on veliparib pharmacokinetics and relative bioavailability in subjects with solid tumors. Cancer Chemother Pharmacol. 2014 Sep;74(3):583-91. doi: 10.1007/s00280-014-2529-2. Epub 2014 Jul 23.
PubMed 25053388
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Randomized, Group Sequential Cross-Over Study Evaluating the Bioavailability and Food Effect of Three Formulations of Veliparib on Pharmacokinetics in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01199224
- Acronym / sponsor ID
- M11-846
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, veliparib, refractory, relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 10 Sep 2010 (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.
Compare the bioavailability of three veliparib formulations in subjects with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: veliparib |
| Arm B | Experimental | Drug: veliparib |
| Arm C | Experimental | Drug: veliparib |
| Arm D | Experimental | Drug: veliparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy.
- In the opinion of the Investigator, life expectancy is 12 weeks or greater.
- Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.
Key exclusion criteria (9 listed)
- The subject is unable to swallow capsules or has nausea or vomiting.
- Female subject is pregnant or breast-feeding.
- Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome).
- History of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (pH) or absorption.
- Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
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 |
|---|---|---|
| veliparibAlso: ABT-888veliparib formulation A | Drug | Arm A |
| veliparibAlso: ABT-888veliparib formulation B | Drug | Arm B |
| veliparibAlso: ABT-888veliparib formulation C | Drug | Arm C |
| veliparibAlso: ABT-888, velaparibveliparib formulation C | Drug | Arm D |
Primary outcome
Assess the oral bioavailability of veliparib
Time frame: Up to 4 weeks.
Assess the relative bioavailability of Formulation A, Formulation B and Formulation C with or without food measured using area under the plasma concentration-time curve (AUC), the maximum observed plasma concentration (Cmax), and time to Cmax (Tmax).
1 secondary outcome
To evaluate the safety and tolerability of veliparib in patients with solid tumors
Time frame: Up to 4 weeks
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 21 Nov 2017.
- Results publication: PubMed 25053388Mostafa NM, Chiu YL, Rosen LS, Bessudo A, Kovacs X, Giranda VL. A phase 1 study to evaluate effect of food on veliparib pharmacokinetics and relative bioavailability in subjects with solid tumors. Cancer Chemother Pharmacol. 2014 Sep;74(3):583-91. doi: 10.1007/s00280-014-2529-2. Epub 2014 Jul 23.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
Bhardwaj Desai, MD study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing veliparib in people with Solid Tumors, run by AbbVie.
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 9 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Assess the oral bioavailability of veliparib (time frame: Up to 4 weeks.). 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 NCT01199224, 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 21 Nov 2017.