Non-hematologic MalignanciesPhase 1NCT00526617
A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients
A Phase 1 study testing ABT-888 and Temozolomide in people with Non-hematologic Malignancies and Metastatic Melanoma, run by AbbVie.
Trial summary
This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Temozolomide (chemotherapy) in treating patients with solid tumors, including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hematologic Malignancies, Metastatic Melanoma, Breast Cancer
- What is being tested?
- ABT-888 and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jun 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
- Dose escalation and expanded safety cohorts
- Evaluable disease, histologically confirmed malignancy (metastatic or unresectable) and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective
- ECOG Performance Score less than or equal to 2
- Adequate hematologic, renal and hepatic function
- Normal sodium, calcium and magnesium levels
- Voluntarily signed informed consent
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- Expanded Safety Cohorts Only
- Population:
- Metastatic melanoma (MM)
- Hepatocellular carcinoma (HCC) Child Pugh Category A and B classification only
- BRCA deficient tumor status*: advanced breast cancer (with soft tissue disease), or advanced ovarian cancer, or advanced primary peritoneal cancer, or advanced fallopian tube cancer*
- Patients must have histologically or cytologically confirmed solid tumors with a positive genetic test result documenting BRCA 1 or BRCA 2 mutation status, to be considered eligible.
- Serial tumor biopsies: Required for all subjects enrolled in one of the Expanded Low Dose Safety Cohorts.
Who cannot join
- Dose Escalation and Expanded Safety Cohorts
- Known central nervous system (CNS) metastases or CNS primary cancer.
- Previous or current malignancies at other sites, except: adequately treated in situ carcinoma of cervix uteri; basal/squamous cell carcinoma of skin; previous malignancy considered cured.
- Previous history or current seizure disorder.
- Clinically significant and uncontrolled major medical condition(s) or any medical condition that places the subject at an unacceptably high risk for toxicities.
- Transplant recipients and patients receiving combination anti-retroviral therapy for HIV due to the use of immunosuppressant therapies.
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- Lactating or pregnant female.
- Chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy will not be allowed within either 4 weeks, or 5 half lives of a targeted therapy prior to study drug administration (Study Day 1).
- Prior therapy with regimens containing dacarbazine (DTIC) or TMZ is not permitted.
- Anti-cancer therapy is not permitted during the treatment portion of the study.
- Hormone therapy, bisphosphonates or LHRH-agonists for prostate cancer are permitted prior to and during the study.
- Significant adverse event or toxicity due to previous anti-cancer treatment that has not recovered to within one grade level (not to exceed Grade 2) of baseline.
- Expanded Safety Cohorts Only:
- MM Only: Prior treatment with DNA damaging agents or cytotoxic chemotherapy including carboplatin, cisplatin, fotemustine, paclitaxel, vincristine, TMZ and DTIC.
- Prior therapy with biologic agents (including IL-2, interferon, bevacizumab, vaccines and immunostimulants) and signal transduction inhibitors (including sorafenib, erlotinib, sutent and elesclomol) are allowed.
- Lower Dose Expanded Safety Cohorts Only
- Anti-coagulant restrictions for subjects that have tumor biopsies.
About this study
Official title: A Phase I Study of ABT-888 in Combination With Temozolomide (TMZ) in Subjects With Non-Hematologic Malignancies (NHM) and Metastatic Melanoma (MM)
This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Temozolomide (chemotherapy) in treating patients with solid tumors, including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC).
Read the detailed description
A Phase 1, multicenter, dose-escalation study evaluating the safety and tolerability of the PARP inhibitor ABT-888 in combination with Temozolomide (TMZ) in subjects with non-hematologic malignancies (NHM), including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC).
- Conditions
- Non-hematologic Malignancies, Metastatic Melanoma, Breast Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- ABT-888, Temozolomide
- Keywords
- Solid Tumor, Melanoma, Breast cancer, Ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, Hepatocellular carcinoma, HCC, BRCA deficient, BRCA mutation, Temozolomide, Temodar, TMZ, ABT-888, PARP inhibitor
- Medical subject headings
- Melanoma, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-888Drug
Oral capsules
TemozolomideDrug
Also called Temodar, TMZ
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Within each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ. Receives: Drug: ABT-888; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: Duration of Study
Safety and Tolerability
Measured: Duration of Study
Pharmacokinetic Profile
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJun 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 Non-hematologic MalignanciesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT00526617
- Sponsor's protocol ID
- M06-862
- Status last verified
- Jan 2012
- First submitted
- 5 Sep 2007
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Nuthalapati S, Munasinghe W, Giranda V, Xiong H. Clinical Pharmacokinetics and Mass Balance of Veliparib in Combination with Temozolomide in Subjects with Nonhematologic Malignancies. Clin Pharmacokinet. 2018 Jan;57(1):51-58. doi: 10.1007/s40262-017-0547-z.
PubMed 28497258
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 I Study of ABT-888 in Combination With Temozolomide (TMZ) in Subjects With Non-Hematologic Malignancies (NHM) and Metastatic Melanoma (MM)
- ClinicalTrials.gov ID
- NCT00526617
- Acronym / sponsor ID
- M06-862
- Conditions
- Non-hematologic Malignancies, Metastatic Melanoma, Breast Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- Keywords
- Solid Tumor, Melanoma, Breast cancer, Ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, Hepatocellular carcinoma, HCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2010 (actual)
- First posted
- 10 Sep 2007 (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 Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Temozolomide (chemotherapy) in treating patients with solid tumors, including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC).
Detailed description
A Phase 1, multicenter, dose-escalation study evaluating the safety and tolerability of the PARP inhibitor ABT-888 in combination with Temozolomide (TMZ) in subjects with non-hematologic malignancies (NHM), including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: ABT-888, Drug: TemozolomideWithin each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Dose escalation and expanded safety cohorts
- Evaluable disease, histologically confirmed malignancy (metastatic or unresectable) and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective
- ECOG Performance Score less than or equal to 2
- Adequate hematologic, renal and hepatic function
- Normal sodium, calcium and magnesium levels
Key exclusion criteria (17 listed)
- Dose Escalation and Expanded Safety Cohorts
- Known central nervous system (CNS) metastases or CNS primary cancer.
- Previous or current malignancies at other sites, except: adequately treated in situ carcinoma of cervix uteri; basal/squamous cell carcinoma of skin; previous malignancy considered cured.
- Previous history or current seizure disorder.
- Clinically significant and uncontrolled major medical condition(s) or any medical condition that places the subject at an unacceptably high risk for toxicities.
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 |
|---|---|---|
| ABT-888Oral capsules | Drug | Open Label |
| TemozolomideAlso: Temodar, TMZOral capsules | Drug | Open Label |
Primary outcome
Maximum Tolerated Dose
Time frame: Duration of Study
Safety and Tolerability
Time frame: Duration of Study
Pharmacokinetic Profile
Time frame: Duration of Study
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 28497258Nuthalapati S, Munasinghe W, Giranda V, Xiong H. Clinical Pharmacokinetics and Mass Balance of Veliparib in Combination with Temozolomide in Subjects with Nonhematologic Malignancies. Clin Pharmacokinet. 2018 Jan;57(1):51-58. doi: 10.1007/s40262-017-0547-z.
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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 ABT-888 and Temozolomide in people with Non-hematologic Malignancies and Metastatic Melanoma, 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 13 inclusion and 17 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?
Maximum Tolerated Dose (time frame: Duration of Study). The study lists 3 primary outcomes in all. 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 NCT00526617, 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.