Cancer - OvarianPhase 1NCT03400306
A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
A Phase 1 study testing Veliparib, capsule, Veliparib, tablet and Carboplatin in people with Cancer - Ovarian, run by AbbVie.
Trial summary
This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Cancer - Ovarian
- What is being tested?
- Veliparib, capsule, Veliparib, tablet and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2021to 16 Nov 2021
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.
- Life expectancy of 12 weeks or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Able to swallow and retain oral medication.
- Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.
- Non-childbearing potential.
Who cannot join
- History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- Evidence of refractory ascites.
- Has clinically relevant or significant electrocardiogram abnormalities.
About this study
Official title: A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.
- Conditions
- Cancer - Ovarian
- Being tested
- Veliparib, capsule, Veliparib, tablet, Carboplatin, Paclitaxel
- Keywords
- Cancer - Ovarian cancer, Bioavailability, Pharmacokinetics, Bioequivalence
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veliparib, capsuleDrug
Also called ABT-888
capsule; 50 mg or 100 mg
Veliparib, tabletDrug
Also called ABT-888
tablet; 400 mg
CarboplatinDrug
Also called Paraplatin
Intravenous
PaclitaxelDrug
Also called Taxol
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Bioequivalence Sequence Group 1 | Experimental | Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions. Receives: Drug: Veliparib, capsule; Drug: Veliparib, tablet |
| Part 2, Extension | Experimental | Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. Receives: Drug: Veliparib, capsule; Drug: Carboplatin; Drug: Paclitaxel |
| Part 1, Bioequivalence Sequence Group 2 | Experimental | Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions. Receives: Drug: Veliparib, capsule; Drug: Veliparib, tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Maximum observed plasma concentration (Cmax)
Measured: Up to approximately 8 days after initial dose of study drug
Time to Maximum Observed Plasma Concentration (Tmax)
Time to maximum observed plasma concentration (Tmax).
Measured: Up to approximately 8 days after initial dose of study drug
Apparent Terminal Phase Elimination Rate Constant (β or Beta)
Apparent terminal phase elimination rate constant (β or Beta).
Measured: Up to approximately 8 days after initial dose of study drug
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life (t1/2)
Measured: Up to approximately 8 days after initial dose of study drug
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
Measured: Up to approximately 8 days after initial dose of study drug
AUC from time 0 to infinite time (AUC∞)
AUC from time 0 to infinite time (AUC∞)
Measured: Up to approximately 8 days after initial dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start15 Nov 2021 (estimated)
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer - OvarianStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400306
- Sponsor's protocol ID
- M15-536
- Other IDs
- 2018-000313-20, 2018
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2018
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03400306
- Acronym / sponsor ID
- M15-536
- Conditions
- Cancer - Ovarian
- Keywords
- Cancer - Ovarian cancer, Bioavailability, Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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 study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1, Bioequivalence Sequence Group 1 | Experimental | Drug: Veliparib, capsule, Drug: Veliparib, tabletVeliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions. |
| Part 2, Extension | Experimental | Drug: Veliparib, capsule, Drug: Carboplatin, Drug: PaclitaxelVeliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. |
| Part 1, Bioequivalence Sequence Group 2 | Experimental | Drug: Veliparib, capsule, Drug: Veliparib, tabletVeliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.
- Life expectancy of 12 weeks or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Able to swallow and retain oral medication.
Key exclusion criteria (3 listed)
- History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- Evidence of refractory ascites.
- Has clinically relevant or significant electrocardiogram abnormalities.
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, capsuleAlso: ABT-888capsule; 50 mg or 100 mg | Drug | Part 1, Bioequivalence Sequence Group 1, Part 1, Bioequivalence Sequence Group 2, Part 2, Extension |
| Veliparib, tabletAlso: ABT-888tablet; 400 mg | Drug | Part 1, Bioequivalence Sequence Group 1, Part 1, Bioequivalence Sequence Group 2 |
| CarboplatinAlso: ParaplatinIntravenous | Drug | Part 2, Extension |
| PaclitaxelAlso: TaxolIntravenous | Drug | Part 2, Extension |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to approximately 8 days after initial dose of study drug
Maximum observed plasma concentration (Cmax)
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to approximately 8 days after initial dose of study drug
Time to maximum observed plasma concentration (Tmax).
Apparent Terminal Phase Elimination Rate Constant (β or Beta)
Time frame: Up to approximately 8 days after initial dose of study drug
Apparent terminal phase elimination rate constant (β or Beta).
Terminal Phase Elimination Half-life (t1/2)
Time frame: Up to approximately 8 days after initial dose of study drug
Terminal phase elimination half-life (t1/2)
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Time frame: Up to approximately 8 days after initial dose of study drug
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
AUC from time 0 to infinite time (AUC∞)
Time frame: Up to approximately 8 days after initial dose of study drug
AUC from time 0 to infinite time (AUC∞)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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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.
ABBVIE INC. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Veliparib, capsule, Veliparib, tablet and Carboplatin in people with Cancer - Ovarian, 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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 Dec 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum observed plasma concentration (Cmax) (time frame: Up to approximately 8 days after initial dose of study drug). The study lists 6 primary outcomes in all. 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 8 Dec 2021.