NeoplasmsPhase 1NCT01323933
First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors
A Phase 1 study testing AB0024 in people with Neoplasms, run by Gilead Sciences at 2 sites in United States.
Trial summary
Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- AB0024
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Mar 2012
- 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
- Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available
- Measurable or evaluable disease
- ECOG Performance Status of ≤2
- No known active central nervous system (CNS) tumors or CNS metastases
- Adequate organ function
Who cannot join
- Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- History of surgery within 28 days prior to enrollment or anticipated surgery during the study period
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 28 days of study Day 1 (six weeks for nitrosoureas, mitomycin C, antibodies, or molecular agents with t½ >10 days); (concurrent use of hormone therapy for breast or prostate cancer is permitted)
- Treatment with immune modulators including, but not limited to, cyclosporine and tacrolimus within two weeks prior to enrollment
- Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy; (low-dose warfarin [<2 mg/day] for prophylaxis against central venous catheter thrombosis is allowed)
- Patient with tumor that is infiltrating or invading a major blood vessel
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Advanced Solid Tumors
Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024.
Read the detailed description
This is a first-in-human, open-label, sequential dose escalation study to evaluate AB0024 in patients with advanced solid tumors. The study will consist of two parts: Part A will be a dose escalation, and Part B will be a dose expansion.The primary objective of this study is to characterize the safety, tolerability, and PK of AB0024 after multiple IV administrations in patients with advanced solid tumors. The secondary objectives are to measure the tumor response by modified RECIST and to evaluate the formation of anti-AB0024 antibodies.
Patients will receive infusions of AB0024 every two weeks. Patients will be seen weekly for safety assessments and collection of blood samples. Patients who do not show evidence of disease progression by clinical assessment or by CT or MRI may continue receiving AB0024 every 2 weeks until disease progression (clinical or radiographic), study drug intolerance, or withdrawal of consent.
- Conditions
- Neoplasms
- Being tested
- AB0024
- Keywords
- Solid tumors, Oncology, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB0024Drug
Comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| AB0024 | Experimental | The starting dose for Part A will be 1 mg/kg. Subsequent doses of 3, 10, and 20 mg/kg are planned. Three to 6 patients will be enrolled using a 3 + 3 design. Doses of AB0024 will be administered on Days 1, 15, 29, and 43 to characterize the safety, tolerability, and PK.
The dose expansion phase of the study will begin upon completion of the dose escalation phase. Up to 20 patients will be enrolled into one or two cohorts of Part B. The first expansion cohort will be dosed up to the MTD defined as the highest dose level with an observed incidence of DLT in <33% of patients enrolled from Part A. Receives: Drug: AB0024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors.
Measured: Day 71
Secondary outcomes (1)
To measure the tumor response by modified Response Evaluation Criteria in Solid Tumors (RECIST) and to evaluate the formation of anti-AB0024 antibodies.
Measured: Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patricia LoRusso, DO, Principal investigator, Barbara Ann Karmanos Cancer InstituteAnthony Tolcher, MD, Principal investigator, South Texas Accelerated Research Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323933
- Sponsor's protocol ID
- AB0024-101
- Status last verified
- May 2012
- First submitted
- 24 Mar 2011
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Barker HE, Cox TR, Erler JT. The rationale for targeting the LOX family in cancer. Nat Rev Cancer. 2012 Jul 19;12(8):540-52. doi: 10.1038/nrc3319.
PubMed 22810810
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01323933
- Acronym / sponsor ID
- AB0024-101
- Conditions
- Neoplasms
- Keywords
- Solid tumors, Oncology, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Mar 2011 (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.
Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024.
Detailed description
This is a first-in-human, open-label, sequential dose escalation study to evaluate AB0024 in patients with advanced solid tumors. The study will consist of two parts: Part A will be a dose escalation, and Part B will be a dose expansion.The primary objective of this study is to characterize the safety, tolerability, and PK of AB0024 after multiple IV administrations in patients with advanced solid tumors. The secondary objectives are to measure the tumor response by modified RECIST and to evaluate the formation of anti-AB0024 antibodies.
Patients will receive infusions of AB0024 every two weeks. Patients will be seen weekly for safety assessments and collection of blood samples. Patients who do not show evidence of disease progression by clinical assessment or by CT or MRI may continue receiving AB0024 every 2 weeks until disease progression (clinical or radiographic), study drug intolerance, or withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB0024 | Experimental | Drug: AB0024The starting dose for Part A will be 1 mg/kg. Subsequent doses of 3, 10, and 20 mg/kg are planned. Three to 6 patients will be enrolled using a 3 + 3 design. Doses of AB0024 will be administered on Days 1, 15, 29, and 43 to characterize the safety, tolerability, and PK. The dose expansion phase of the study will begin upon completion of the dose escalation phase. Up to 20 patients will be enrolled into one or two cohorts of Part B. The first expansion cohort will be dosed up to the MTD defined as the highest dose level with an observed incidence of DLT in <33% of patients enrolled from Part A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available
- Measurable or evaluable disease
- ECOG Performance Status of ≤2
- No known active central nervous system (CNS) tumors or CNS metastases
- Adequate organ function
Key exclusion criteria (6 listed)
- Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- History of surgery within 28 days prior to enrollment or anticipated surgery during the study period
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 28 days of study Day 1 (six weeks for nitrosoureas, mitomycin C, antibodies, or molecular agents with t½ >10 days); (concurrent use of hormone therapy for breast or prostate cancer is permitted)
- Treatment with immune modulators including, but not limited to, cyclosporine and tacrolimus within two weeks prior to enrollment
- Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy; (low-dose warfarin [<2 mg/day] for prophylaxis against central venous catheter thrombosis is allowed)
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 |
|---|---|---|
| AB0024Comparison of different dosages of drug | Drug | AB0024 |
Primary outcome
To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors.
Time frame: Day 71
1 secondary outcome
To measure the tumor response by modified Response Evaluation Criteria in Solid Tumors (RECIST) and to evaluate the formation of anti-AB0024 antibodies.
Time frame: Day 71
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 3 May 2012.
- Derived from this study: PubMed 22810810Barker HE, Cox TR, Erler JT. The rationale for targeting the LOX family in cancer. Nat Rev Cancer. 2012 Jul 19;12(8):540-52. doi: 10.1038/nrc3319.
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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.
Patricia LoRusso, DO principal investigator
Barbara Ann Karmanos Cancer Institute
Anthony Tolcher, MD principal investigator
South Texas Accelerated Research Therapeutics
2 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 AB0024 in people with Neoplasms, run by Gilead Sciences 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 5 inclusion and 6 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 3 May 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 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 characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors. (time frame: Day 71). 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 NCT01323933, 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 3 May 2012.