Solid Tumor CancersPhase 2NCT01193140
To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors
A Phase 2 study testing veliparib and Temozolomide in people with Solid Tumor Cancers, run by Abbott at 2 sites in United States.
Trial summary
To evaluate the safety and tolerability of the veliparib/TMZ combination 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 Tumor Cancers
- What is being tested?
- veliparib and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Nov 2011
- Phase
- Phase 2
- 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
- Subject has completed study participation in Study M11-846
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- Subject must have adequate hematologic, renal and hepatic function per institutional normal range as follows: • Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3 (1.5 × 109/L); Platelets ≥ 100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L); • Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) range OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal; • Hepatic function: AST and ALT ≤ 2.5 × the ULN range. For subjects with liver metastases, AST and ALT < 5 × the ULN range; Bilirubin ≤ 1.5 × the ULN range. • Partial Thromboplastin Time (PTT) must be ≤ 1.5 × the ULN range and INR < 1.5. Subjects on anticoagulant therapy (such as Coumadin) will have an appropriate PTT and INR as determined by the Investigator.
- Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to initiation of treatment and a negative urine pregnancy test on Cycle 1 Day 1 and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. • Total abstinence from sexual intercourse (minimum one complete menstrual cycle); • Vasectomized partner; • Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; • Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream); • IUD (Intrauterine Device).
Who cannot join
- Subject has received anticancer agent(s) or an investigational agent (except for veliparib) within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
- Subject has undergone major surgery within the previous 28 days prior to study drug administration.
- Subject has received radiotherapy within 28 days prior to study drug administration.
- Clinically significant and uncontrolled major medical condition(s) including but not limited to: • Active uncontrolled infection; • Symptomatic congestive heart failure;• Unstable angina pectoris or cardiac arrhythmia; • 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.
- Subject is pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site Reference ID/Investigator# 43022
Encinitas, California, 92024
Site Reference ID/Investigator# 42662
Santa Monica, California, 90404
About this study
Official title: An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.
To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with solid tumors.
Read the detailed description
An extension study to evaluate the safety of veliparib in combination with temozolomide in subjects with solid tumors
- Conditions
- Solid Tumor Cancers
- Being tested
- veliparib, Temozolomide
- Keywords
- veliparib, relapsed and refractory tumors, Temodar, temozolomide, ABT-888, Solid Tumors
- Medical subject headings
- Recurrence, 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
Dose orally twice daily for 7 days, consecutively, every cycle
TemozolomideDrug
Also called Temodar
Dose orally once daily for 5 days, consecutively, every cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: veliparib; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors
Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments
Measured: Continuous starting with Day1 and 30 Days following last dose.
Secondary outcomes (1)
To assess effect of veliparib/TMZ combination regimen on progression free survival, overall survival, the objective response rate, time to progression and Eastern Cooperative Oncology Group (ECOG) performance status in subjects with solid tumors
Measured: Every 12 weeks from Day1 and continuing up to 18 months following last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhardwaj Dessai, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193140
- Sponsor's protocol ID
- M12-273
- Status last verified
- Nov 2012
- First submitted
- 28 Jul 2010
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.
- ClinicalTrials.gov ID
- NCT01193140
- Acronym / sponsor ID
- M12-273
- Conditions
- Solid Tumor Cancers
- Keywords
- veliparib, relapsed and refractory tumors, Temodar, temozolomide, ABT-888, Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 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.
To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with solid tumors.
Detailed description
An extension study to evaluate the safety of veliparib in combination with temozolomide in subjects with solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: veliparib, Drug: Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has completed study participation in Study M11-846
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- Subject must have adequate hematologic, renal and hepatic function per institutional normal range as follows: • Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3 (1.5 × 109/L); Platelets ≥ 100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L); • Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) range OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal; • Hepatic function: AST and ALT ≤ 2.5 × the ULN range. For subjects with liver metastases, AST and ALT < 5 × the ULN range; Bilirubin ≤ 1.5 × the ULN range. • Partial Thromboplastin Time (PTT) must be ≤ 1.5 × the ULN range and INR < 1.5. Subjects on anticoagulant therapy (such as Coumadin) will have an appropriate PTT and INR as determined by the Investigator.
- Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to initiation of treatment and a negative urine pregnancy test on Cycle 1 Day 1 and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. • Total abstinence from sexual intercourse (minimum one complete menstrual cycle); • Vasectomized partner; • Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; • Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream); • IUD (Intrauterine Device).
Key exclusion criteria (5 listed)
- Subject has received anticancer agent(s) or an investigational agent (except for veliparib) within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
- Subject has undergone major surgery within the previous 28 days prior to study drug administration.
- Subject has received radiotherapy within 28 days prior to study drug administration.
- Clinically significant and uncontrolled major medical condition(s) including but not limited to: • Active uncontrolled infection; • Symptomatic congestive heart failure;• Unstable angina pectoris or cardiac arrhythmia; • 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.
- Subject is pregnant or lactating.
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-888Dose orally twice daily for 7 days, consecutively, every cycle | Drug | Arm A |
| TemozolomideAlso: TemodarDose orally once daily for 5 days, consecutively, every cycle | Drug | Arm A |
Primary outcome
To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors
Time frame: Continuous starting with Day1 and 30 Days following last dose.
Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments
1 secondary outcome
To assess effect of veliparib/TMZ combination regimen on progression free survival, overall survival, the objective response rate, time to progression and Eastern Cooperative Oncology Group (ECOG) performance status in subjects with solid tumors
Time frame: Every 12 weeks from Day1 and continuing up to 18 months following last dose.
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 2012.
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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
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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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 Dessai, MD study director
Abbott
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing veliparib and Temozolomide in people with Solid Tumor Cancers, run by Abbott at 2 sites in United States.
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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors (time frame: Continuous starting with Day1 and 30 Days following last dose.). 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 21 Nov 2012.