Hematologic MalignanciesPhase 1NCT00642031
Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies
A Phase 1 study testing Triciribine in people with Hematologic Malignancies and Leukemia, run by Prescient Therapeutics, Ltd. at 2 sites in United States.
Trial summary
Primary objective: To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies; To determine the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Malignancies, Leukemia
- What is being tested?
- Triciribine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO classification] and chronic myelomonocytic leukemia (CMML) are also candidates for this protocol.
- CONTINUATION # 1: Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by World Health Organization (WHO) classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible;
- ECOG performance status of 0- 3;
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Pregnant and nursing patients are excluded because the effects of Triciribine on a fetus or nursing child are unknown;
- Must be able and willing to give written informed consent;
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 48hours before initiation of treatment on this protocol. Persistent chronic clinically significant toxicities from prior chemotherapy must not be greater than grade 1; and
- Patients must have the following clinical laboratory values, unless abnormal parameter level is considered related to leukemia: Creatinine (Cr) less than or equal to 2.0 mg/dL, Bilirubin Normal limits (less than or equal to 1.5 * Upper Limit of Normal (ULN) with liver metastases) unless considered due to Gilbert's syndrome, Aspartate aminotransferase (AST) less than or equal to 3.0 * ULN, Alanine aminotransferase (ALT) less than or equal to 3.0 * ULN
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure; and
- Patients receiving any other standard or investigational treatment for their hematologic malignancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT MD Anderson Cancer Center
Houston, Texas, 77030
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies
Primary objective:
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies;
To determine the pharmacokinetics (PK) of Triciribine following study drug administration.
Secondary objective:
To observe the anti-tumor effects of Triciribine, if any occur
Read the detailed description
Triciribine is designed to prevent development of certain proteins which participate in the abnormal growth of cancer cells.
Before you can start treatment on this study, you will have "baseline tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will be asked about your ability to perform everyday activities. You will have blood (about 4 teaspoons) and urine collected for routine tests. You will have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test.
You will also have a bone marrow aspiration and/or biopsy performed during the baseline testing. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle.
Certain patients who are at risk for involvement of disease in their central nervous system may be required to have a lumbar puncture (spinal tap) done. A lumbar puncture involves inserting a needle between the vertebrae of the back and then removing a small amount of spinal fluid. The fluid will be checked for diseased cells, used to measure the level of study drug in the fluid, and used to measure the level of a substance that shows how the study drug is being handled by your body.
If you are found to be eligible for this study, you will start receiving Triciribine through a needle in a vein, over about 1 hour, on Days 1, 8, and 15 of each 28-day study "cycle." On each day you receive Triciribine, your vital signs will be measured before the start of the infusion, at 30 minutes (half-way through the infusion), at the end of the infusion, and at 1 hour after completing the infusion. An ECG will be done at the end of the infusion on Day 1 of the first cycle only.
The amount of Triciribine you receive in each infusion will depend on when you enter the study. At least 3 participants will be enrolled at each dose level. Each new group of participants will receive a higher dose level than the group before, unless a level is reached where the side effects are considered intolerable. This will help researchers to find out the highest tolerable dose of Triciribine.
During the study, researchers will be checking the status of the cancer to see how it is responding to the study drug. You will be checked once a week, or more often, depending on how you are doing and according to your blood cell counts. Each check-up includes measurement of your vital signs and blood (about 4 teaspoons) drawn for routine tests. You will be asked about any side effects you may have experienced and any medications you are taking.
During Cycle 1, you will have blood samples (about 1 teaspoon each time) drawn to measure the amount of study drug in your blood at different times. This is called pharmacokinetic (PK) testing. During Cycle 1, you will have a blood sample drawn before receiving the first dose of Triciribine, and then 2, 24, 48, 72 ,and 96 hours after the Day 1 Triciribine dose. If your doctor decides that it is necessary, an additional blood sample will also be drawn between 120 and 144 hours (about 5-6 days) after your Day 1 dose of Triciribine. During Cycle 1, you may also have blood samples (about 1 teaspoon) drawn to measure the action of the study drug in the tumor cells. This is called pharmacodynamic studies (this defines how the drug works on the tumor cells). During Cycle 1, you will have a blood sample drawn (about 1 teaspoon) before receiving the first dose of triciribine and then 2 and 24 hours after the Day 1 triciribine dose.
Before receiving each additional cycle, you will have a physical exam, including vital signs. Blood (about 4 teaspoons) will be drawn for routine tests, and urine will be collected. You will be asked about your ability to perform everyday activities. You will have a bone marrow exam (including aspiration and/or biopsy) about every 28 days, in order to check your response.
Certain participants who are at risk for involvement of disease in their central nervous system may be required to have repeat lumbar punctures (spinal taps) performed once a week.
You may move to a higher dose level after your first cycle of therapy, if that increased dose level is considered safe and the disease is stable or responding to treatment. If, however, you experience serious side effects from the therapy, the doctor may decide to hold any further therapy with Triciribine until those side effects go away, or may decide to stop therapy altogether, if the side effects are intolerable. Depending on how fast the side effects go away, you may be able to re-start your Triciribine infusions at a lower dose.
You may continue to receive Triciribine on study with no limit to the number of cycles that you can receive, as long as your doctor finds that you are benefiting from this therapy and you are not experiencing intolerable side effects. On the other hand, you may stop receiving the study drug and be taken off study if it is not effective for you and/or the disease gets worse, you develop another illness that interferes with the ability to safely give you the study drug, or you are unable to tolerate the study drug.
If you leave the study for any reason, you will be asked to return for a follow-up visit at the end of therapy (and possibly 30 days after your last dose of Triciribine, if you are not receiving another type of treatment). A physical exam will be performed, and blood (about 2 teaspoons) will be drawn for routine tests, during both of these visits. If you have side effects that are possibly related to the treatment, you may need to have more follow-up visits. Blood (up to 3 tablespoons) may need to be drawn for routine tests at that time.
THIS IS AN INVESTIGATIONAL STUDY. Triciribine has been authorized by the FDA for use in research only. Up to 34 patients will take part in this multicenter study. Up to 30 patients will be enrolled at M. D. Anderson.
- Conditions
- Hematologic Malignancies, Leukemia
- Being tested
- Triciribine
- Keywords
- Hematologic Malignancies, Leukemia, Chronic Myelomonocytic Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Agnogenic Myeloid Metaplasia, Triciribine Phosphate Monohydrate, Triciribine, TCN-PM, VD-0002
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Leukemia, Myelomonocytic, Chronic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriciribineDrug
Also called Triciribine Phosphate Monohydrate, TCN-PM, VD-0002
15 mg/m^2 IV Weekly Over 1 Hour On Days 1, 8, and 15.
| Study group | Role | What they receive |
|---|---|---|
| Triciribine | Experimental | Triciribine 15 mg/m^2 intravenous (IV) Weekly Over 1 Hour On Days 1, 8, and 15. Receives: Drug: Triciribine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of TCN-PM (Triciribine)
The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). Evaluations after each dose level (28 day cycle).
Measured: 28 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startAug 2006
- Primary completionOct 2012
- Study completionOct 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 Hematologic MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prescient Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VioQuest Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Farhad Ravandi-Kashani, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642031
- Sponsor's protocol ID
- 2006-0249
- Status last verified
- Aug 2016
- First submitted
- 18 Mar 2008
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sampath D, Malik A, Plunkett W, Nowak B, Williams B, Burton M, Verstovsek S, Faderl S, Garcia-Manero G, List AF, Sebti S, Kantarjian HM, Ravandi F, Lancet JE. Phase I clinical, pharmacokinetic, and pharmacodynamic study of the Akt-inhibitor triciribine phosphate monohydrate in patients with advanced hematologic malignancies. Leuk Res. 2013 Nov;37(11):1461-7. doi: 10.1016/j.leukres.2013.07.034. Epub 2013 Aug 6.
PubMed 23993427
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00642031
- Acronym / sponsor ID
- 2006-0249
- Conditions
- Hematologic Malignancies, Leukemia
- Keywords
- Hematologic Malignancies, Leukemia, Chronic Myelomonocytic Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Agnogenic Myeloid Metaplasia, Triciribine Phosphate Monohydrate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prescient Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- VioQuest Pharmaceuticals
- Study start
- Aug 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Mar 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.
Primary objective:
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies;
To determine the pharmacokinetics (PK) of Triciribine following study drug administration.
Secondary objective:
To observe the anti-tumor effects of Triciribine, if any occur
Detailed description
Triciribine is designed to prevent development of certain proteins which participate in the abnormal growth of cancer cells.
Before you can start treatment on this study, you will have "baseline tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will be asked about your ability to perform everyday activities. You will have blood (about 4 teaspoons) and urine collected for routine tests. You will have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test.
You will also have a bone marrow aspiration and/or biopsy performed during the baseline testing. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle.
Certain patients who are at risk for involvement of disease in their central nervous system may be required to have a lumbar puncture (spinal tap) done. A lumbar puncture involves inserting a needle between the vertebrae of the back and then removing a small amount of spinal fluid. The fluid will be checked for diseased cells, used to measure the level of study drug in the fluid, and used to measure the level of a substance that shows how the study drug is being handled by your body.
If you are found to be eligible for this study, you will start receiving Triciribine through a needle in a vein, over about 1 hour, on Days 1, 8, and 15 of each 28-day study "cycle." On each day you receive Triciribine, your vital signs will be measured before the start of the infusion, at 30 minutes (half-way through the infusion), at the end of the infusion, and at 1 hour after completing the infusion. An ECG will be done at the end of the infusion on Day 1 of the first cycle only.
The amount of Triciribine you receive in each infusion will depend on when you enter the study. At least 3 participants will be enrolled at each dose level. Each new group of participants will receive a higher dose level than the group before, unless a level is reached where the side effects are considered intolerable. This will help researchers to find out the highest tolerable dose of Triciribine.
During the study, researchers will be checking the status of the cancer to see how it is responding to the study drug. You will be checked once a week, or more often, depending on how you are doing and according to your blood cell counts. Each check-up includes measurement of your vital signs and blood (about 4 teaspoons) drawn for routine tests. You will be asked about any side effects you may have experienced and any medications you are taking.
During Cycle 1, you will have blood samples (about 1 teaspoon each time) drawn to measure the amount of study drug in your blood at different times. This is called pharmacokinetic (PK) testing. During Cycle 1, you will have a blood sample drawn before receiving the first dose of Triciribine, and then 2, 24, 48, 72 ,and 96 hours after the Day 1 Triciribine dose. If your doctor decides that it is necessary, an additional blood sample will also be drawn between 120 and 144 hours (about 5-6 days) after your Day 1 dose of Triciribine. During Cycle 1, you may also have blood samples (about 1 teaspoon) drawn to measure the action of the study drug in the tumor cells. This is called pharmacodynamic studies (this defines how the drug works on the tumor cells). During Cycle 1, you will have a blood sample drawn (about 1 teaspoon) before receiving the first dose of triciribine and then 2 and 24 hours after the Day 1 triciribine dose.
Before receiving each additional cycle, you will have a physical exam, including vital signs. Blood (about 4 teaspoons) will be drawn for routine tests, and urine will be collected. You will be asked about your ability to perform everyday activities. You will have a bone marrow exam (including aspiration and/or biopsy) about every 28 days, in order to check your response.
Certain participants who are at risk for involvement of disease in their central nervous system may be required to have repeat lumbar punctures (spinal taps) performed once a week.
You may move to a higher dose level after your first cycle of therapy, if that increased dose level is considered safe and the disease is stable or responding to treatment. If, however, you experience serious side effects from the therapy, the doctor may decide to hold any further therapy with Triciribine until those side effects go away, or may decide to stop therapy altogether, if the side effects are intolerable. Depending on how fast the side effects go away, you may be able to re-start your Triciribine infusions at a lower dose.
You may continue to receive Triciribine on study with no limit to the number of cycles that you can receive, as long as your doctor finds that you are benefiting from this therapy and you are not experiencing intolerable side effects. On the other hand, you may stop receiving the study drug and be taken off study if it is not effective for you and/or the disease gets worse, you develop another illness that interferes with the ability to safely give you the study drug, or you are unable to tolerate the study drug.
If you leave the study for any reason, you will be asked to return for a follow-up visit at the end of therapy (and possibly 30 days after your last dose of Triciribine, if you are not receiving another type of treatment). A physical exam will be performed, and blood (about 2 teaspoons) will be drawn for routine tests, during both of these visits. If you have side effects that are possibly related to the treatment, you may need to have more follow-up visits. Blood (up to 3 tablespoons) may need to be drawn for routine tests at that time.
THIS IS AN INVESTIGATIONAL STUDY. Triciribine has been authorized by the FDA for use in research only. Up to 34 patients will take part in this multicenter study. Up to 30 patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triciribine | Experimental | Drug: TriciribineTriciribine 15 mg/m^2 intravenous (IV) Weekly Over 1 Hour On Days 1, 8, and 15. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO classification] and chronic myelomonocytic leukemia (CMML) are also candidates for this protocol.
- CONTINUATION # 1: Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by World Health Organization (WHO) classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible;
- ECOG performance status of 0- 3;
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Pregnant and nursing patients are excluded because the effects of Triciribine on a fetus or nursing child are unknown;
- Must be able and willing to give written informed consent;
Key exclusion criteria (3 listed)
- Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure; and
- Patients receiving any other standard or investigational treatment for their hematologic malignancy.
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 |
|---|---|---|
| TriciribineAlso: Triciribine Phosphate Monohydrate, TCN-PM, VD-000215 mg/m^2 IV Weekly Over 1 Hour On Days 1, 8, and 15. | Drug | Triciribine |
Primary outcome
Maximum tolerated dose (MTD) of TCN-PM (Triciribine)
Time frame: 28 day cycle
The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). Evaluations after each dose level (28 day cycle).
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 9 Aug 2016.
- Derived from this study: PubMed 23993427Sampath D, Malik A, Plunkett W, Nowak B, Williams B, Burton M, Verstovsek S, Faderl S, Garcia-Manero G, List AF, Sebti S, Kantarjian HM, Ravandi F, Lancet JE. Phase I clinical, pharmacokinetic, and pharmacodynamic study of the Akt-inhibitor triciribine phosphate monohydrate in patients with advanced hematologic malignancies. Leuk Res. 2013 Nov;37(11):1461-7. doi: 10.1016/j.leukres.2013.07.034. Epub 2013 Aug 6.
- The University of Texas M.D.Anderson Cancer CenterLink 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.
Farhad Ravandi-Kashani, MD principal investigator
M.D. Anderson Cancer Center
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 Triciribine in people with Hematologic Malignancies and Leukemia, run by Prescient Therapeutics, Ltd. 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 7 inclusion and 3 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 9 Aug 2016. 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?
Maximum tolerated dose (MTD) of TCN-PM (Triciribine) (time frame: 28 day cycle). 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 NCT00642031, 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 9 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.