Acute LeukemiaPhase 1/2NCT02930109
A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
A Phase 1/2 study testing PTX-200 and Cytarabine in people with Acute Leukemia, run by Prescient Therapeutics, Ltd. at 2 sites in United States.
Trial summary
A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- PTX-200 and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Dec 2016to 4 Mar 2024
- Phase
- Phase 1/2
- 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
- Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
- Age ≥ 18 years
- ECOG Performance Status 0-2
- Patients must be able to give adequate informed consent
Who cannot join
- Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
- Uncontrolled Disseminated Intravascular Coagulation (DIC)
- Uncontrolled diabetes mellitus
- Active, uncontrolled infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Cancer Center
Fairway, Kansas, 60069
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.
Read the detailed description
Study design: Phase I/II study The Phase I study is open-label with four increasing dose levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each cycle.
The Phase II study is open label with administration of the recommended phase dose of PTX-200 for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the Phase I and Phase II parts of the study.
- Conditions
- Acute Leukemia
- Being tested
- PTX-200, Cytarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-200Drug
Also called Triciribine Phosphate Monohydrate
During the Phase I study, increasing dose levels of PTX-200 will be administered as an intravenous infusion on Day 1 each cycle. Triciribine will be infused over 1 hour on Day 1 of each 21 day cycle. The initial dose level will be 25 mg/m2 and each dose level will be increased by 10 mg/m2 to a maximum dose of 55 mg/m2
CytarabineDrug
Also called Ara-C
Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| PTX-200 and cytarabine | Experimental | PTX-200 administered intravenously over 1 hour
Phase I: 4 dose levels: 25 to 55 mg/m2 (with reduction to 15 mg/m2 if needed.
Phase II: maximum tolerated dose. given as a 1 hour infusion
Cytarabine administered by continuous infusion at a dose of 400 mg/m2/day for 4 days. Receives: Drug: PTX-200; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)
Measured: 12 months
Secondary outcomes (1)
Phospho-Akt (pAkt) expression within CD34+ leukemic blasts
Change from baseline phospho-Akt (pAkt) signaling within CD34+ leukemic blasts and the ability of PTX-200 to downregulate p-Akt and its signaling at a variety of times
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start9 Dec 2016
- Primary completion31 Oct 2023
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prescient Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Lancet, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930109
- Sponsor's protocol ID
- PTX-200-AML-015
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2016
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
- ClinicalTrials.gov ID
- NCT02930109
- Acronym / sponsor ID
- PTX-200-AML-015
- Conditions
- Acute Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Prescient Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 12 Oct 2016 (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.
A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.
Detailed description
Study design: Phase I/II study The Phase I study is open-label with four increasing dose levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each cycle.
The Phase II study is open label with administration of the recommended phase dose of PTX-200 for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the Phase I and Phase II parts of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTX-200 and cytarabine | Experimental | Drug: PTX-200, Drug: CytarabinePTX-200 administered intravenously over 1 hour Phase I: 4 dose levels: 25 to 55 mg/m2 (with reduction to 15 mg/m2 if needed. Phase II: maximum tolerated dose. given as a 1 hour infusion Cytarabine administered by continuous infusion at a dose of 400 mg/m2/day for 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
- Age ≥ 18 years
- ECOG Performance Status 0-2
- Patients must be able to give adequate informed consent
Key exclusion criteria (4 listed)
- Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
- Uncontrolled Disseminated Intravascular Coagulation (DIC)
- Uncontrolled diabetes mellitus
- Active, uncontrolled infection
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 |
|---|---|---|
| PTX-200Also: Triciribine Phosphate MonohydrateDuring the Phase I study, increasing dose levels of PTX-200 will be administered as an intravenous infusion on Day 1 each cycle. Triciribine will be infused over 1 hour on Day 1 of each 21 day cycle. The initial dose level will be 25 mg/m2 and each dose level will be increased by 10 mg/m2 to a maximum dose of 55 mg/m2 | Drug | PTX-200 and cytarabine |
| CytarabineAlso: Ara-CCytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle. | Drug | PTX-200 and cytarabine |
Primary outcome
Treatment-related Adverse Events
Time frame: 12 months
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)
1 secondary outcome
Phospho-Akt (pAkt) expression within CD34+ leukemic blasts
Time frame: 12 months
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 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Jeffrey Lancet, MD principal investigator
Moffitt 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 1/2 study testing PTX-200 and Cytarabine in people with Acute 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 4 inclusion and 4 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 5 Apr 2024. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Treatment-related Adverse Events (time frame: 12 months). 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 5 Apr 2024.