A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
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| ClinicalTrials.gov Identifier: NCT02930109 |
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Recruitment Status :
Recruiting
First Posted : October 12, 2016
Last Update Posted : February 9, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Leukemia | Drug: PTX-200 Drug: Cytarabine | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Masking Description: | Open Label |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia |
| Actual Study Start Date : | September 2016 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PTX-200 and cytarabine
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. |
Drug: PTX-200
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
Other Name: Triciribine Phosphate Monohydrate Drug: Cytarabine Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle.
Other Name: Ara-C |
- 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)
- Phospho-Akt (pAkt) expression within CD34+ leukemic blasts [ Time Frame: 12 months ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930109
| Contact: Claudia Gregorio-King | claudia@ptxtherapeutics.com |
| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: William Cisceros 813-745-2071 William.CisnerosPrada@moffitt.org | |
| Principal Investigator: Jeffrey Lancet, MD | |
| United States, Kansas | |
| University of Kansas Cancer Center | Recruiting |
| Fairway, Kansas, United States, 60069 | |
| Contact: Emily Kelly 913-588-4714 ekelly4@kumc.edu | |
| Principal Investigator: Tara Lin, MD | |
| Principal Investigator: | Jeffrey Lancet, MD | Moffitt Cancer Center |
| Responsible Party: | Prescient Therapeutics, Ltd. |
| ClinicalTrials.gov Identifier: | NCT02930109 |
| Other Study ID Numbers: |
PTX-200-AML-015 |
| First Posted: | October 12, 2016 Key Record Dates |
| Last Update Posted: | February 9, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Leukemia Acute Disease Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes Cytarabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |