Chronic Lymphocytic LeukemiaPhase 1NCT00743028
Assess the Oral Bioavailability of New ABT-263 Formulations
A Phase 1 study testing ABT-263 in people with Chronic Lymphocytic Leukemia and Lymphomas, run by Abbott at 5 sites in United States.
Trial summary
This is a randomized, open-label, multicenter crossover study to determine the oral bioavailability of new ABT-263 formulations relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Lymphomas, Leukemias
- What is being tested?
- ABT-263
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2008to Aug 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
- > or =18 years of age;
- Non-hematologic malignancy or hematologic malignancy that is either relapsed or refractory to standard therapy, or failed up to 5 prior standard therapies or no know effective therapy exists;
- 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 1st dose of study drug;
- ECOG performance score of < or = 1;
- Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
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- ANC > or = 1,000/µl;
- Platelets > or = 100,000/mm3;
- Hemoglobin > or = 9.0 g/dL;
- serum creatinine < or = 2.0 mg/dL or calculated creatinine clearance > or = 50;
- AST and ALT < or = 3.0 x ULN; Bilirubin < or = 1.5 x ULN. Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN;
- aPTT, PT not to exceed 1.2 x ULN;
- Females must be surgically sterile, postmenopausal, have negative pregnancy test at screening;
- Females not surgically sterile or postmenopausal \& non-vasectomized males must practice at least one of the following methods of birth control:
- Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to starting study drug);
- Vasectomized partner;
- Hormonal contraceptives for at least 3 months prior to study;
- Double-barrier method (including condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
Who cannot join
- History of/clinically suspicious for cancer-related CNS disease; An allogeneic stem cell transplant.
- Underlying, predisposing condition of bleeding/currently exhibits signs of bleeding.
- History of non-chemotherapy induced thrombocytopenic associated bleeding w/i 1 year prior to the 1st dose.
- Peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- Active ITP/ history of being refractory to platelet transfusions.
- Significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic/hepatic disease.
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- Females pregnant or breast-feeding.
- History of or active medical condition(s) that affects absorption or motility.
- Positive for HIV.
- Other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; neutropenic fever w/i 1 wk prior to study drug.
- Steroid therapy w/i 7 days prior to 1st dose for anti-cancer intent.
- Anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (except hormones for hypothyroidism or ERT)/agonists required to suppress serum testosterone levels [e.g. LHRH, GnRH], any investigational therapy w/i 14 days prior to first dose of study drug.
- Biologic agent w/i 30 days prior to 1st dose.
- Anticoagulation therapy/drugs/herbal supplements affecting platelet function.
- Aspirin w/i 7 days prior to 1st dose.
- Grapefruit/grapefruit products.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Site Reference ID/Investigator# 16341
Bethesda, Maryland, 20892
Site Reference ID/Investigator# 10281
Encinitas, California, 92024
Site Reference ID/Investigator# 20041
Hackensack, New Jersey, 07601
Site Reference ID/Investigator# 9441
Lebanon, New Hampshire, 03756
Site Reference ID/Investigator# 10282
Santa Monica, California, 90404
About this study
Official title: A Single Dose Study Evaluating the Oral Bioavailability and Pharmacokinetics of the Capsule Formulation of ABT-263 in Subjects With Cancer
This is a randomized, open-label, multicenter crossover study to determine the oral bioavailability of new ABT-263 formulations relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 36 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.
- Conditions
- Chronic Lymphocytic Leukemia, Lymphomas, Leukemias
- Being tested
- ABT-263
- Keywords
- Other hematological and non-hematological malignancies
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-263Drug
Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2 studies vs. a single dose of one of the new ABT-263 formulation
ABT-263Drug
Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.
ABT-263Drug
Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ABT-263 |
| 2 | Experimental | Not described Receives: Drug: ABT-263 |
| 3 | Experimental | Not described Receives: Drug: ABT-263 |
| 4 | Experimental | Not described Receives: Drug: ABT-263 |
| 5 | Experimental | Not described Receives: Drug: ABT-263 |
| 6 | Experimental | Not described Receives: Drug: ABT-263 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies.
Measured: Two Period crossover design.
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies and assess new ABT-263 formulations after once daily dosing (QD) and twice daily dosing (BID).
Measured: Three Period crossover design.
Secondary outcomes (1)
Safety measures include number and percentage of subjects having treatment-emergent adverse events tabulated by MedDRA system organ class and preferred term, laboratory test results, lymphocyte enumeration results, vital signs, etc.
Measured: Two and three period crossover design
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743028
- Sponsor's protocol ID
- M10-454
- Status last verified
- Sep 2010
- First submitted
- 26 Aug 2008
- Last updated
- 7 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study Evaluating the Oral Bioavailability and Pharmacokinetics of the Capsule Formulation of ABT-263 in Subjects With Cancer
- ClinicalTrials.gov ID
- NCT00743028
- Acronym / sponsor ID
- M10-454
- Conditions
- Chronic Lymphocytic Leukemia, Lymphomas, Leukemias
- Keywords
- Other hematological and non-hematological malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- First posted
- 28 Aug 2008 (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 randomized, open-label, multicenter crossover study to determine the oral bioavailability of new ABT-263 formulations relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 36 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-263 |
| 2 | Experimental | Drug: ABT-263 |
| 3 | Experimental | Drug: ABT-263 |
| 4 | Experimental | Drug: ABT-263 |
| 5 | Experimental | Drug: ABT-263 |
| 6 | Experimental | Drug: ABT-263 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- > or =18 years of age;
- Non-hematologic malignancy or hematologic malignancy that is either relapsed or refractory to standard therapy, or failed up to 5 prior standard therapies or no know effective therapy exists;
- 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 1st dose of study drug;
- ECOG performance score of < or = 1;
Key exclusion criteria (16 listed)
- History of/clinically suspicious for cancer-related CNS disease; An allogeneic stem cell transplant.
- Underlying, predisposing condition of bleeding/currently exhibits signs of bleeding.
- History of non-chemotherapy induced thrombocytopenic associated bleeding w/i 1 year prior to the 1st dose.
- Peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- Active ITP/ history of being refractory to platelet transfusions.
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-263Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2 studies vs. a single dose of one of the new ABT-263 formulation | Drug | 1, 2 |
| ABT-263Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days. | Drug | 3, 4 |
| ABT-263Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days. | Drug | 5, 6 |
Primary outcome
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies.
Time frame: Two Period crossover design.
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies and assess new ABT-263 formulations after once daily dosing (QD) and twice daily dosing (BID).
Time frame: Three Period crossover design.
1 secondary outcome
Safety measures include number and percentage of subjects having treatment-emergent adverse events tabulated by MedDRA system organ class and preferred term, laboratory test results, lymphocyte enumeration results, vital signs, etc.
Time frame: Two and three period crossover design
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 7 Oct 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.
5 sites 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 in people with Chronic Lymphocytic Leukemia and Lymphomas, run by Abbott at 5 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 18 inclusion and 16 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 7 Oct 2010. 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. 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?
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies. (time frame: Two Period crossover design.). The study lists 2 primary outcomes in all. 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 7 Oct 2010.