Breast CancerPhase 1NCT02033551
A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors
A Phase 1 study testing Veliparib, Carboplatin and Paclitaxel in people with Breast Cancer and Ovarian Cancer, run by AbbVie at 5 sites in 3 countries.
Trial summary
This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Colon Cancer
- What is being tested?
- Veliparib, Carboplatin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Dec 2013to Sep 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
- For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.
- If the subject has 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 comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).
- Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.
Who cannot join
- Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:
- Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;
- Uncontrolled nausea/vomiting/diarrhea;
- Active uncontrolled infection;
- Symptomatic congestive heart failure;
- Unstable angina pectoris or cardiac arrhythmia;
Show all 12Show fewer
- Psychiatric illness/social situation that would limit compliance with study requirements;
- Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
- Subjects who have hypersensitivity to Carboplatin, Paclitaxel or Cremophor should be excluded from arm B.
- Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
- Subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug.
- The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Site Reference ID/Investigator# 117415
San Antonio, Texas, 78229
Site Reference ID/Investigator# 117416
Scottsdale, Arizona, 85258
Netherlands2 sites
Site Reference ID/Investigator# 117337
Groningen, 9713 GZ
Site Reference ID/Investigator# 117338
Maastricht, 6229 HX
About this study
Official title: An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors
This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.
- Conditions
- Breast Cancer, Ovarian Cancer, Colon Cancer, Lung Cancer, Gastric Cancer, Solid Tumors
- Being tested
- Veliparib, Carboplatin, Paclitaxel, FOLFIRI
- Keywords
- Gastric Cancer, Lung Cancer, PARP Inhibitor, Ovarian Cancer, Solid Tumors, Breast Cancer, Colon Cancer
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Colonic Neoplasms, Lung Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeliparibDrug
Also called ABT-888
CarboplatinDrug
PaclitaxelDrug
Also called Taxol
FOLFIRIDrug
combination of Fluorouracil, leucovorin and irinotecan
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Veliparib Monotherapy | Experimental | Subjects in this arm will be dosed with Veliparib continuous dosing. Receives: Drug: Veliparib |
| Arm B - Veliparib in Combination with Carboplatin & Paclitaxel | Experimental | Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy. Receives: Drug: Veliparib; Drug: Carboplatin; Drug: Paclitaxel |
| Arm C Veliparib in Combination with Modified FOLFIRI | Experimental | Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy. Receives: Drug: Veliparib; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: Measured up to 30 days after the last dose of study drug.
Secondary outcomes (7)
Objective Response Rate (ORR)
Measured: Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.
Overall Survival (OS)
Measured: Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first.
Time to Disease Progression (TTP)
Measured: Assessed at each visit up to 18 months after the last subject has enrolled in the study.
Progression Free Survival (PFS)
Measured: Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study.
Clinical Laboratory Tests
Hematology, Chemistry, Urinalysis
Measured: Up to 18 months.
Electrocardiogram
Measured: Up to 18 months.
Tumor Assessment
A computerized tomography scan to document the size of the tumor.
Measured: Up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacie Shepherd, PhD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033551
- Sponsor's protocol ID
- M14-144
- Other IDs
- 2013-003137-16
- Status last verified
- Sep 2016
- First submitted
- 8 Jan 2014
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT02033551
- Acronym / sponsor ID
- M14-144
- Conditions
- Breast Cancer, Ovarian Cancer, Colon Cancer, Lung Cancer, Gastric Cancer, Solid Tumors
- Keywords
- Gastric Cancer, Lung Cancer, PARP Inhibitor, Ovarian Cancer, Solid Tumors, Breast Cancer, Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Jan 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 an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A - Veliparib Monotherapy | Experimental | Drug: VeliparibSubjects in this arm will be dosed with Veliparib continuous dosing. |
| Arm B - Veliparib in Combination with Carboplatin & Paclitaxel | Experimental | Drug: Veliparib, Drug: Carboplatin, Drug: PaclitaxelSubjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy. |
| Arm C Veliparib in Combination with Modified FOLFIRI | Experimental | Drug: Veliparib, Drug: FOLFIRISubjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
- For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.
- If the subject has 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 comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).
- Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.
Key exclusion criteria (12 listed)
- Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:
- Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;
- Uncontrolled nausea/vomiting/diarrhea;
- Active uncontrolled infection;
- Symptomatic congestive heart failure;
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-888 | Drug | Arm A - Veliparib Monotherapy, Arm B - Veliparib in Combination with Carboplatin & Paclitaxel, Arm C Veliparib in Combination with Modified FOLFIRI |
| Carboplatin | Drug | Arm B - Veliparib in Combination with Carboplatin & Paclitaxel |
| PaclitaxelAlso: Taxol | Drug | Arm B - Veliparib in Combination with Carboplatin & Paclitaxel |
| FOLFIRIcombination of Fluorouracil, leucovorin and irinotecan | Drug | Arm C Veliparib in Combination with Modified FOLFIRI |
Primary outcome
Number of subjects with adverse events
Time frame: Measured up to 30 days after the last dose of study drug.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.
Overall Survival (OS)
Time frame: Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first.
Time to Disease Progression (TTP)
Time frame: Assessed at each visit up to 18 months after the last subject has enrolled in the study.
Progression Free Survival (PFS)
Time frame: Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study.
Clinical Laboratory Tests
Time frame: Up to 18 months.
Electrocardiogram
Time frame: Up to 18 months.
Tumor Assessment
Time frame: Up to 18 months.
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 27 Sep 2016.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Stacie Shepherd, PhD study director
AbbVie
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Veliparib, Carboplatin and Paclitaxel in people with Breast Cancer and Ovarian Cancer, run by AbbVie at 5 sites in 3 countries.
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 12 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Netherlands, Spain. 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?
Number of subjects with adverse events (time frame: Measured up to 30 days after the last dose of study drug.). 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 27 Sep 2016.