Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Digestive System Diseases

Mouth and Tooth Diseases

Rare Diseases

Hematologic Neoplasms

Graft vs Host Disease

Mucositis

Hematologic Diseases

Homologous Wasting Disease

Acute Graft Versus Host Disease

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Angiotensin I (1-7)

Angiotensin II

Angiotensinogen

Single-arm safety/efficacy trial of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation for the treatment of hematologic malignancies. Treatment dose is 300 mcg/kg/day TXA127.

TXA127

Mary J Laughlin, MD

The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double umbilical cord blood transplantation (UCBT). The study will also evaluate the effects of TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and platelet recovery; platelet transfusion requirements; immune reconstitution; and duration of corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce rapid production of neutrophils and platelets in the bloodstream, as well as increase the immune system components. TXA127 has also been shown reduce the severity of chemotherapy-induced mucositis.

Cord blood (CB) as a hematopoietic stem cell source has multiple advantages. Cord blood is normally discarded at birth and can easily be collected and stored. Availability of numerous CB banks has resulted in genetically diverse CB units including those from non-Caucasians. Once a suitable CB unit is located, confirmatory typing can be quickly performed and a donor unit can be shipped to the transplant center. Furthermore, because a CB graft results in a lower incidence of graft-versus-host disease (GVHD), one or two antigen-mismatches may be acceptable for transplantation. Despite these advantages, CB has a significant drawback: the number of hematopoietic stem cells obtained from a unit of CB is significantly lower than from a bone marrow (BM) or peripheral blood stem cell (PBSC) harvest. The number of stem cells can be increased by transplanting two cord blood units, however the incidence of GVHD increases in patients receiving two CB units compared to patients who receive one unit. Another issue in this population is mucositis, as a result of myeloablative conditioning given prior to the transplant, which can be debilitating to patients. TXA127 is pharmaceutically-formulated angiotensin 1-7, a non-hypertensive derivative of angiotensin II (which contains the 8th amino acid conferring receptor binding to blood pressure receptors). TXA127 has multilineage effects on hematopoietic progenitors in vitro and in vivo. The hematopoietic properties demonstrated in preclinical and clinical studies support the investigation of TXA127 to reduce the incidence of acute GVHD (aGVHD) and mucositis in this patient population.

Efficacy Study of a TXA127 to Reduce Acute Graft-vs-Host Disease in Subjects Undergoing Double Umbilical Cord Blood Transplantation

Phase II Evaluation of the Efficacy of TXA127 (Angiotensin 1-7) to Reduce Acute Graft-vs-Host Disease in Adults Undergoing Double Umbilical Cord Blood Transplantation

Incidence of Grade II-IV acute graft-vs-host disease (aGVHD) will be assessed using clinical staging and grading criteria as defined in Przepiorka et al. (1995). Duration and severity of aGVHD will also be evaluated.

Incidence of mucositis is defined by the occurrence of least one adverse event with MedDRA preferred term that includes "mucositis" or "stomatitis". The severity grade will be determined by NCI-CTCAE.

Time to initial neutrophil engraftment is defined as the number of days from infusion of UCB units to the first of 3 consecutive days of an ANC ≥0.5 × 10\^9/L. Time to initial platelet recovery is defined as the number of days from infusion of UCB units to the first of 3 consecutive platelet count measurements tested on different days with a count ≥20 × 10\^9/L with no platelet transfusion in the prior 7 days.

Platelet transfusion requirements are based on cumulative units of platelets transfused and cumulative days of platelet transfusions.

Immune reconstitution will be assessed via the measurement of peripheral blood concentrations of CD3+, CD4+, CD8+, CD19+, and CD56+ cells (performed at Study Days 62 and 100).

Duration of corticosteroid use for GVHD will be summarized by frequency (i.e., number of days).

Tarix Pharmaceuticals

Symptoms and General Pathology

Syndrome

Preleukemia

Myelodysplastic Syndromes

Thrombocytopenia

Bone Marrow Diseases

Precancerous Conditions

Blood Platelet Disorders

Cytopenia

All cohorts will recieve TXA127; Cohorts receive either 300, 600, or 900 ug/kg daily

Cohorts in this study will receive 300, 600, or 900 ug/kg daily by subcutaneous injection

Gere S diZerega, MD

Phase 1, single-center, open-label, sequential cohort dose escalation study. This is a 3 + 3 design study involving at least 3 subjects in ascending dose cohorts, with subjects participating up to 10 weeks.

The overall study objectives are to evaluate the safety and tolerability of TXA127 in thrombocytopenic subjects with low or intermediate-1 risk MDS.

Evaluation of the platelet response and the erythroid and granulocytic responses to TXA127 will provide preliminary efficacy data.

The hematopoietic properties demonstrated in the preclinical and clinical studies support the investigation of TXA127 to stimulate stem cell and progenitor cell proliferation. This is an exploratory study in a limited population of low or intermediate-1 MDS subjects who have platelet counts of ≤50 x 109/L to evaluate the effects of TXA127 on platelet response and on granulocytic and erythroid response.

Platelet response will be defined as complete and major as below:

* Complete platelet response: increase of platelet count to \>100 x 109/L
* Major platelet response: increase of absolute platelet count by \>30 x 109/L Other responses will be according to modified IWG MDS criteria (2006). Daily subcutaneous dosing of TXA will be carried out both in the clinic at scheduled visits and at home between clinic visits for a period fo 28 days.

Phase I Study Evaluating TXA127 in Low/Intermediate-1 Risk Myelodysplastic Syndrome and Thrombocytopenia

Phase 1 Open-Label Dose-Escalating Study Evaluating the Safety and Preliminary Efficacy of TXA127 in Patients With Low/Intermediate-1 Risk Myelodysplastic Syndrome and Thrombocytopenia

Evaluations performed during the study include vital signs and physical exam at all visits (twice/week for 4 weeks of treatment and at follow-up visits occurring 2 \& 4 weeks following last treatment), blood chemistry, CBC, and platelet counts (once per week for 4 weeks, and at follow-up visits), concomitant medication and adverse event evaluations throughout the study period (8 weeks).

Safety and tolerability will be assessed by incidence, severity, and changes from baseline of all relevant parameters including adverse events (AEs), laboratory values, and vital signs

Platelet counts and response will be evaluated twice per week at clinic visits during the treatment period (4 weeks), and again at the follow-up visits (week 6 and week 8).

Erythroid and granulocytic responses will be evaluated once weekly during the treatment period (first visit of each treatment week), and again at the follow-up clinic visits.

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Lymphoma, Non-Hodgkin

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Hodgkin Lymphoma

300mcg/kg/day administered subcutaneously up to 28 days

300mcg/kg/day, administered subcutaneously for up to 28 days

300mcg/kg/day administered subcutaneously for up to 28 days

Placebo

Michael Schuster, MD

The purpose of this study is to determine the safety and effectiveness of TXA127 in accelerating the time it takes for patients to recover their platelet counts following a Autologous Peripheral Blood Stem Cell transplant.

* This is a randomized, double-blind (Investigator and Study Subject), placebo-controlled study.
* The conditioning regimen and mobilization agents used will be up to the discretion of the Study Center Investigator

Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients

Phase II Study Evaluating the Safety and Efficacy of TXA127 in the Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Hodgkin Lymphoma, Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Limited Reinfusion of CD34+ Cells

Evaluate the effectiveness of TXA127 in accelerating the time to initial platelet recovery following PBSC transplant with a limited number of CD34+ cells, defined as CD34+ cell concentrations ≥1.5 x 106 and ≤5.0 x 106 CD34+ cells/kg. Platelet recovery is defined as that day the subject achieves a post-nadir platelet count of ≥20 x 109/L with no platelet transfusion in the prior 7 days.

Evaluate the safety of TXA127 administration following PBSC transplant

Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs \> 0.5 x 10⁹/L)

Evaluate the incidence of mucositis Grade 3/4

Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC \<0.5 x 109/L)

Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed

Constant Therapeutics LLC

Nutritional and Metabolic Diseases

Metabolic Diseases

300mcg/kg/day, subcutaneous injection for up to 28 days

Kristin Page, MD

Joanne Kurtzberg, MD

Engraftment failure is a major obstacle to the success of cord blood transplantation in children with malignancies and inherited metabolic disorders, despite the fact that they receive relatively high doses of nucleated cells from UCB. TXA127 is pharmaceutically formulated Angiotensin 1-7 \[A(1-7)\], a non-hypertensive derivative of Angiotensin-II (which contains the 8th amino acid conferring receptor binding to blood pressure receptors). TXA127 has multilineage effects on hematopoietic progenitors in vitro and in vivo. Preclinical data show that TXA127 is a novel stimulator of early multilineage hematopoietic progenitors, increases engraftment of committed hematopoietic progenitors, and induces more rapid production of platelets and neutrophils in the peripheral circulation, especially in limited cell number transplants. Treatment with TXA127 following UCBT is expected to increase the numbers of hematopoietic progenitors and accelerate engraftment.

Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Pediatric Patients Undergoing Single or Double Umbilical Cord Blood Transplantation

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Anemia

Neutropenia

Lymphopenia

Agranulocytosis

Leukopenia

Leukocyte Disorders

Immunologic Deficiency Syndromes

Ovarian Cancer

Ovarian Epithelial Cancer

Granulocytopenia

Antineoplastic Agents

Gemcitabine

Combination gemcitabine and platinum-based chemotherapy with concurrent placebo

Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127

Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127

Once daily subcutaneous injection of 100 ug/kg

Once daily subcutaneous injection of 300 ug/kg

Once daily subcutaneous injection of placebo

This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.

This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.

Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.

Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.

Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:

Regimen A

* Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
* Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on Day 8 of the cycle.

Regimen B

* Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
* Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle

TXA127 will be self-administered as a subcutaneous injection by the subject once daily on Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for hematologic analysis on Days 1, 8 and 15 of each treatment cycle.

Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer

Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma

Mean percentage of cycles with platelet counts below 50,000/mm3

Number of subjects who experienced a platelet count below 50,000/mm3

Mean percentage of treatment cycles where platelets counts were below 25,000/mm3

Mean percentage of cycles where projected (target) chemotherapy dose was maintained

Number of subjects with a treatment emergent adverse event of lymphopenia

Number of subjects with a treatment emergent adverse event of neutropenia

Number of subjects with a treatment emergent adverse event of anemia

Number of subjects with a treatment emergent adverse event of mucositis

Number of subjects with a treatment emergent adverse event of alopecia

Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:

1. Transfusions
2. Filgrastim or Pegfilgrastim
3. Erythropoietin
4. Palifermin

The assessment types were coded using MedDRA.

Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo

Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127

TXA127 100 ug/kg

Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127

TXA127 300 ug/kg

TXA127 300ug/kg

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Feasibility considerations (e.g., slow patient enrollment and lower incidence of Grade 3-4 thrombocytopenia than planned) necessitated early termination of the study after 34 patients had been enrolled.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Study of a TXA127 to Reduce Acute Graft-vs-Host Disease in Subjects Undergoing Double Umbilical Cord Blood Transplantation	NCT01882374	Hematologic Mal...	TXA127	18 Years -	Tarix Pharmaceuticals
Phase I Study Evaluating TXA127 in Low/Intermediate-1 Risk Myelodysplastic Syndrome and Thrombocytopenia	NCT01362036	Myelodysplastic...	TXA127	18 Years - 65 Years	Tarix Pharmaceuticals
Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients	NCT01121120	Lymphoma, Non-H... Hodgkin Disease Multiple Myelom...	TXA127 Placebo	18 Years -	Tarix Pharmaceuticals
Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Pediatric Patients Undergoing Single or Double Umbilical Cord Blood Transplantation	NCT01554254	Cord Blood Tran... Hematologic Mal... Inherited Metab...	TXA127	6 Months - 20 Years	Tarix Pharmaceuticals
Efficacy Study of a TXA127 to Reduce Acute Graft-vs-Host Disease in Subjects Undergoing Double Umbilical Cord Blood Transplantation	NCT01882374	Hematologic Mal...	TXA127	18 Years -	Tarix Pharmaceuticals
Phase I Study Evaluating TXA127 in Low/Intermediate-1 Risk Myelodysplastic Syndrome and Thrombocytopenia	NCT01362036	Myelodysplastic...	TXA127	18 Years - 65 Years	Tarix Pharmaceuticals
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer	NCT00771810	Thrombocytopeni... Neutropenia Lymphopenia Anemia	TXA127 TXA127 Placebo	18 Years -	Tarix Pharmaceuticals

Spots Global Cancer Trial Database for txa127

Every month we try and update this database with for txa127 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for txa127

Every month we try and update this database with for txa127 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for txa127 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.