Advanced Solid TumorsPhase 1NCT01063816
A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
A Phase 1 study testing veliparib (ABT-888), carboplatin and gemcitabine in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott).
Trial summary
The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- veliparib (ABT-888), carboplatin and gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Aug 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
- Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.
- Eastern Cooperative Group performance score of 0 to 2.
- Adequate hematologic, hepatic and renal function
- Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years
Who cannot join
- Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.
- Subjects with known history of brain metastases and primary CNS tumors.
- Hypersensitivity reactions to platinum compounds or gemcitabine.
- Clinically significant and uncontrolled major medical conditions
- Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.
About this study
Official title: A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- veliparib (ABT-888), carboplatin, gemcitabine
- Keywords
- PARP Inhibitors
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 Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.
carboplatinDrug
Carboplatin will be dosed on Day 1 of each cycle, intravenously.
gemcitabineDrug
Also called Gemzar
Dosing on Days 1 and 8 of each Cycle, intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: veliparib (ABT-888); Drug: carboplatin; Drug: gemcitabine |
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 2 dose
Measured: ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).
Secondary outcomes (6)
Pharmacokinetics Area Under the Curve (AUC)
Measured: Timepoints: 30 and 45 minutes, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5,6,6.5, 7 and 8 hours past dose
Safety assessment: Electrocardiogram
Measured: Screening, Day 8 of each Cycle of drug and Final Visit
Safety assessment: Clinical Laboratory Tests
Hematology and Chemistry
Measured: Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit
Physical exam including vital signs
Physical exam including blood pressure, pulse and temperature
Measured: Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit
Safety assessment: Adverse event assessments
Collect all adverse events at each visit
Measured: All study visits
Tumor assessment
Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
Measured: Screening, every nine weeks and Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2016
- Study completionAug 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.
- 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark D McKee, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063816
- Sponsor's protocol ID
- M10-758
- Status last verified
- Jul 2021
- First submitted
- 4 Feb 2010
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gray HJ, Bell-McGuinn K, Fleming GF, Cristea M, Xiong H, Sullivan D, Luo Y, McKee MD, Munasinghe W, Martin LP. Phase I combination study of the PARP inhibitor veliparib plus carboplatin and gemcitabine in patients with advanced ovarian cancer and other solid malignancies. Gynecol Oncol. 2018 Mar;148(3):507-514. doi: 10.1016/j.ygyno.2017.12.029. Epub 2018 Jan 17.
PubMed 29352572
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01063816
- Acronym / sponsor ID
- M10-758
- Conditions
- Advanced Solid Tumors
- Keywords
- PARP Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Feb 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.
The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in 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 |
|---|---|---|
| Arm 1 | Experimental | Drug: veliparib (ABT-888), Drug: carboplatin, Drug: gemcitabine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.
- Eastern Cooperative Group performance score of 0 to 2.
- Adequate hematologic, hepatic and renal function
- Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years
Key exclusion criteria (5 listed)
- Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.
- Subjects with known history of brain metastases and primary CNS tumors.
- Hypersensitivity reactions to platinum compounds or gemcitabine.
- Clinically significant and uncontrolled major medical conditions
- Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.
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 Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method. | Drug | Arm 1 |
| carboplatinCarboplatin will be dosed on Day 1 of each cycle, intravenously. | Drug | Arm 1 |
| gemcitabineAlso: GemzarDosing on Days 1 and 8 of each Cycle, intravenously. | Drug | Arm 1 |
Primary outcome
Determine the maximum tolerated dose and recommended Phase 2 dose
Time frame: ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).
6 secondary outcomes
Pharmacokinetics Area Under the Curve (AUC)
Time frame: Timepoints: 30 and 45 minutes, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5,6,6.5, 7 and 8 hours past dose
Safety assessment: Electrocardiogram
Time frame: Screening, Day 8 of each Cycle of drug and Final Visit
Safety assessment: Clinical Laboratory Tests
Time frame: Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit
Physical exam including vital signs
Time frame: Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit
Safety assessment: Adverse event assessments
Time frame: All study visits
Tumor assessment
Time frame: Screening, every nine weeks and Final Visit
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 2 Aug 2021.
- Background: PubMed 29352572Gray HJ, Bell-McGuinn K, Fleming GF, Cristea M, Xiong H, Sullivan D, Luo Y, McKee MD, Munasinghe W, Martin LP. Phase I combination study of the PARP inhibitor veliparib plus carboplatin and gemcitabine in patients with advanced ovarian cancer and other solid malignancies. Gynecol Oncol. 2018 Mar;148(3):507-514. doi: 10.1016/j.ygyno.2017.12.029. Epub 2018 Jan 17.
- Related InfoLink provided by the sponsor.
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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.
Mark D McKee, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing veliparib (ABT-888), carboplatin and gemcitabine in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott).
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 2 Aug 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 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 2 dose (time frame: ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).). 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 NCT01063816, 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 2 Aug 2021.