Solid TumorPhase 1NCT01041235
Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid Tumors Who Have Failed Previous Therapies
A Phase 1 study testing ATI-1123 (active drug = docetaxel) in people with Solid Tumor and Breast Cancer, run by Azaya Therapeutics, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety profile, including the maximum tolerated dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Breast Cancer, Ovarian Cancer
- What is being tested?
- ATI-1123 (active drug = docetaxel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Dec 2011
- 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
- Understand and sign a written IRB-approved informed consent form.
- Have a histologically confirmed solid tumor.
- Have progressive disease following standard/approved chemotherapy or have no appropriate alternative therapy available.
- Have one or more tumors measurable or evaluable as outlined by modified RECIST or evaluable by CT or MRI scan.
- Have an ECOG performance status of ≤ 2.
- Have a life expectancy of at least 3 months.
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- Be ≥ 18 years old.
- Have a negative pregnancy test (if female of childbearing potential)
- Demonstrate acceptable hepatic function:
- Bilirubin ≤ upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
- Demonstrate acceptable renal function:
- Serum creatinine ≤ 1.5 x ULN, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (Calculated according to the Cockroft and Gault formula)
- Demonstrate acceptable hematologic status:
- Absolute neutrophil count ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3 (measured within 72 hours prior to initial dose)
- Hemoglobin ≥ 9 g/dL
- Demonstrate acceptable coagulation status:
- PT or INR within 1.5x ULN
- PTT within 1.5x ULN
- Have recovered from prior treatments (eg, surgery, radiation, chemotherapy, investigational therapies) sufficiently prior to Day 1 so that, in the opinion of the Investigator and/or Medical Monitor, the protocol objectives would not be compromised.
- Agree to use an effective contraceptive method (hormonal or barrier method; or abstinence) for the duration of the study and for 30 days after the last dose (for men and women of child-producing potential).
Who cannot join
- Have New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG).
- Have a seizure disorder requiring anticonvulsant therapy.
- Have active CNS metastasis. Patients with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on stable dose of steroids for ≥ 1 week prior to enrollment.
- Have severe, chronic obstructive pulmonary disease with hypoxemia.
- Have active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- Are pregnant or nursing.
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- Have undergone radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
- Are unwilling or unable to comply with procedures required in this protocol.
- Have a known history of infection with HIV, hepatitis B, or hepatitis C.
- Have a serious nonmalignant disease that, in the opinion of the Investigator and/or the Medical Monitor, could compromise protocol objectives.
- Are currently receiving any other investigational agent.
- Have exhibited allergic reactions to docetaxel, or a similar structural compound, biological agent, or formulation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, 75230
Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered ATI-1123, a Liposomal Docetaxel Formulation, on an Every 3 Week Schedule, in Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety profile, including the maximum tolerated dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer patients with advanced solid tumors.
Read the detailed description
The majority of advanced stage human cancers are fatal if not treated promptly and aggressively. Standard treatments include chemotherapy, radiation therapy and surgery. Docetaxel, the active ingredient in ATI-1123 and the FDA approved drug Taxotere, is a chemotherapy given by IV to patients to treat various types of cancers.
Docetaxel is a poorly water soluble semi-synthetic taxane analog commonly used in the treatment of a variety of solid tumors including non-small cell lung, prostate, breast, gastric and head and neck cancer. Because of its poor water solubility it is formulated with co-solvents that can potentially contribute to treatment related adverse events such as hypersensitivity. Current taxane formulations often complicate drug delivery and can alter both pharmacokinetic and toxicity profiles.
Results from nonclinical evaluations show that ATI-1123 retains the antineoplastic activity of docetaxel while removing the need for unwanted solvents like Tween 80. The administration of ATI-1123 versus other docetaxel chemotherapy formulations is expected to reduce hypersensitivity reactions (redness, swelling, itching at the infusion site), eliminate the requirement for premedications, have a broader therapeutic index, and enhance systemic docetaxel exposure.
- Being tested
- ATI-1123 (active drug = docetaxel)
- Keywords
- Solid Neoplasms, Carcinoma, Breast, Ovarian, Ovary, Pancreas, Pancreatic, Lung, NSCLC, Non Small Cell Lung, Prostate, Gastric, Head and Neck
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-1123 (active drug = docetaxel)Drug
Also called ATI-1123, ATI1123, Docetaxel, Docetaxol
Dose escalation starting at 15 mg/m2 given once every 3 weeks via IV
| Study group | Role | What they receive |
|---|---|---|
| ATI-1123 | Experimental | Not described Receives: Drug: ATI-1123 (active drug = docetaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the (MTD) and (DLTs) of ATI-1123 administered every 3 weeks, over a range of doses in patients with advanced solid tumors.
Measured: Duration of study
To establish the dose recommended for future phase II studies with ATI-1123.
Measured: End of Study
Secondary outcomes (2)
To establish the pharmacokinetics of intravenously administered ATI-1123.
Measured: Cycle 1 (various time points within the cycle)
To observe patients for any evidence of antitumor activity of ATI-1123 by objective radiographic assessment.
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azaya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony W Tolcher, MD, Principal investigator, South Texas Accelerated Research Therapeutics (START)John Nemunaitis, MD, Principal investigator, Mary Crowley Cancer Research CenterJon M Rogers, MD, Study chair, Azaya Therapeutics, Inc (Medical Monitor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041235
- Sponsor's protocol ID
- ATI1123-101
- Status last verified
- Sep 2012
- First submitted
- 30 Dec 2009
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered ATI-1123, a Liposomal Docetaxel Formulation, on an Every 3 Week Schedule, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01041235
- Acronym / sponsor ID
- ATI1123-101
- Keywords
- Solid Neoplasms, Carcinoma, Breast, Ovarian, Ovary, Pancreas, Pancreatic, Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Azaya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Dec 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.
The purpose of this study is to determine the safety profile, including the maximum tolerated dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer patients with advanced solid tumors.
Detailed description
The majority of advanced stage human cancers are fatal if not treated promptly and aggressively. Standard treatments include chemotherapy, radiation therapy and surgery. Docetaxel, the active ingredient in ATI-1123 and the FDA approved drug Taxotere, is a chemotherapy given by IV to patients to treat various types of cancers.
Docetaxel is a poorly water soluble semi-synthetic taxane analog commonly used in the treatment of a variety of solid tumors including non-small cell lung, prostate, breast, gastric and head and neck cancer. Because of its poor water solubility it is formulated with co-solvents that can potentially contribute to treatment related adverse events such as hypersensitivity. Current taxane formulations often complicate drug delivery and can alter both pharmacokinetic and toxicity profiles.
Results from nonclinical evaluations show that ATI-1123 retains the antineoplastic activity of docetaxel while removing the need for unwanted solvents like Tween 80. The administration of ATI-1123 versus other docetaxel chemotherapy formulations is expected to reduce hypersensitivity reactions (redness, swelling, itching at the infusion site), eliminate the requirement for premedications, have a broader therapeutic index, and enhance systemic docetaxel exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATI-1123 | Experimental | Drug: ATI-1123 (active drug = docetaxel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Understand and sign a written IRB-approved informed consent form.
- Have a histologically confirmed solid tumor.
- Have progressive disease following standard/approved chemotherapy or have no appropriate alternative therapy available.
- Have one or more tumors measurable or evaluable as outlined by modified RECIST or evaluable by CT or MRI scan.
- Have an ECOG performance status of ≤ 2.
Key exclusion criteria (12 listed)
- Have New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG).
- Have a seizure disorder requiring anticonvulsant therapy.
- Have active CNS metastasis. Patients with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on stable dose of steroids for ≥ 1 week prior to enrollment.
- Have severe, chronic obstructive pulmonary disease with hypoxemia.
- Have active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
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 |
|---|---|---|
| ATI-1123 (active drug = docetaxel)Also: ATI-1123, ATI1123, Docetaxel, DocetaxolDose escalation starting at 15 mg/m2 given once every 3 weeks via IV | Drug | ATI-1123 |
Primary outcome
To determine the (MTD) and (DLTs) of ATI-1123 administered every 3 weeks, over a range of doses in patients with advanced solid tumors.
Time frame: Duration of study
To establish the dose recommended for future phase II studies with ATI-1123.
Time frame: End of Study
2 secondary outcomes
To establish the pharmacokinetics of intravenously administered ATI-1123.
Time frame: Cycle 1 (various time points within the cycle)
To observe patients for any evidence of antitumor activity of ATI-1123 by objective radiographic assessment.
Time frame: Every 8 weeks
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 6 Sep 2012.
- Mary Crowley Medical Research Center websiteLink provided by the sponsor.
- Azaya (sponsor) websiteLink provided by the sponsor.
- Cancer Therapty and Research Center (CTRC)Link provided by the sponsor.
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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.
Anthony W Tolcher, MD principal investigator
South Texas Accelerated Research Therapeutics (START)
John Nemunaitis, MD principal investigator
Mary Crowley Cancer Research Center
Jon M Rogers, MD study chair
Azaya Therapeutics, Inc (Medical Monitor)
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 ATI-1123 (active drug = docetaxel) in people with Solid Tumor and Breast Cancer, run by Azaya Therapeutics, Inc. 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 22 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 6 Sep 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 determine the (MTD) and (DLTs) of ATI-1123 administered every 3 weeks, over a range of doses in patients with advanced solid tumors. (time frame: Duration of study). 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 6 Sep 2012.