LymphomaPhase 1NCT01021358
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).
A Phase 1 study testing ABT-263 and Ketoconazole in people with Lymphoma and Chronic Lymphocytic Leukemia, run by Abbott at 1 site in United States.
Trial summary
This is a single dose, open-label, single or multiple center study to determine the interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Chronic Lymphocytic Leukemia, Solid Tumors
- What is being tested?
- ABT-263 and Ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 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
- 18 years of age or older.
- Has a non-hematologic malignancy (radiographic, histologic, or cytologic confirmation), or hematologic malignancy (histologic or cytologic confirmation) that is either: relapsed or refractory to standard therapy, failed at least one prior therapy or no known effective therapy exists.
- In the investigator's opinion, the subject's life expectancy is at least 90 days.
- If clinically indicated, (e.g., subjects over the age of 70) subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the first dose of study drug.
- Subjects with 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 CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
Who cannot join
- History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
- Has undergone an allogeneic stem cell transplant.
- Has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
- Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- Has active immune thrombocytopenic purpura or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
- Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease. Female subject is pregnant or breast-feeding.
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- History of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, etc).
- Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; diagnosis of fever and neutropenia within one week prior to study drug administration.
- Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy [ERT], or agonists required to suppress serum testosterone levels [e.g., LHRH, GnRH, etc.] for subjects with prostate cancer
- Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function.
- Currently receiving or requires anti-fungal treatment or CYP3A inhibitors. In the opinion of the Investigator, the subject is an unsuitable candidate to receive ABT-263.
- History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 25068
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-263 (Navitoclax)
This is a single dose, open-label, single or multiple center study to determine the interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer.
- Conditions
- Lymphoma, Chronic Lymphocytic Leukemia, Solid Tumors
- Being tested
- ABT-263, Ketoconazole
- Medical subject headings
- Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-263Drug
Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
KetoconazoleDrug
Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (ABT-263 and Ketoconozole) | Experimental | Not described Receives: Drug: ABT-263; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263.
Measured: Weekly
Secondary outcomes (1)
To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients.
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021358
- Sponsor's protocol ID
- M10-957
- Status last verified
- Dec 2010
- First submitted
- 25 Nov 2009
- Last updated
- 20 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-263 (Navitoclax)
- ClinicalTrials.gov ID
- NCT01021358
- Acronym / sponsor ID
- M10-957
- Conditions
- Lymphoma, Chronic Lymphocytic Leukemia, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- First posted
- 30 Nov 2009 (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 a single dose, open-label, single or multiple center study to determine the interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer.
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 (ABT-263 and Ketoconozole) | Experimental | Drug: ABT-263, Drug: Ketoconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Has a non-hematologic malignancy (radiographic, histologic, or cytologic confirmation), or hematologic malignancy (histologic or cytologic confirmation) that is either: relapsed or refractory to standard therapy, failed at least one prior therapy or no known effective therapy exists.
- In the investigator's opinion, the subject's life expectancy is at least 90 days.
- If clinically indicated, (e.g., subjects over the age of 70) subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the first dose of study drug.
- Subjects with 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 CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
Key exclusion criteria (12 listed)
- History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
- Has undergone an allogeneic stem cell transplant.
- Has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
- Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- Has active immune thrombocytopenic purpura or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
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-263Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole. | Drug | Arm A (ABT-263 and Ketoconozole) |
| KetoconazoleSubjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole. | Drug | Arm A (ABT-263 and Ketoconozole) |
Primary outcome
To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263.
Time frame: Weekly
1 secondary outcome
To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients.
Time frame: Daily
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 20 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-263 and Ketoconazole in people with Lymphoma and Chronic Lymphocytic Leukemia, run by Abbott at 1 site 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 5 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 20 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263. (time frame: Weekly). 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 20 Dec 2010.