Gamitrinib for Lymphoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Fox Chase Cancer Center, Philadelphia, PA
+1 More
Gamitrinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma

Study Summary

A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer

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Eligible Conditions

  • Lymphoma
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Gamitrinib will improve 1 primary outcome and 8 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 7 years.

7 years
Assess the pharmacodynamic effects of gamitrinib
Determine the MTD and/or RP2D of gamitrinib when administered once weekly.
Document any anti-tumor activity of single agent gamitrinib
Evaluate the overall safety profile of intravenously administered single-agent gamitrinib
To evaluate the area under the concentration time curve (AUC0-t) of gamitrinib
To evaluate the clearance (CL) of gamitrinib
To evaluate the coefficient of variation (CV) of gamitrinib
To evaluate the peak concentration (Cmax) of gamitrinib
To evaluate the time to maximum concentration (Tmax) of gamitrinib

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

7 Treatment Groups

No Control Group
Dose 1

This trial requires 42 total participants across 7 different treatment groups

This trial involves 7 different treatments. Gamitrinib is the primary treatment being studied. Participants will be divided into 7 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose 1
Drug
Accelerated Phase: 10 mg Standard Phase: 10 mg
Dose 6
Drug
Accelerated Phase: 320 mg Standard Phase: 85 mg
Dose 5
Drug
Accelerated Phase: 160 mg Standard Phase: 65 mg
Dose -1
Drug
Accelerated Phase: - Standard Phase: 5 mg
Dose 2
Drug
Accelerated Phase: 20 mg Standard Phase: 20 mg
Dose 3
Drug
Accelerated Phase: 40 mg Standard Phase: 35 mg
Dose 4
Drug
Accelerated Phase: 80 mg Standard Phase: 50 mg

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 years for reporting.

Closest Location

Fox Chase Cancer Center - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed diagnosis of advanced cancer refractory to standard of care therapy, or for whom no standard of care therapy is available. Any numbers of prior therapies are allowed.
Dose escalation phase: Solid tumors and lymphoma may have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) or as per RECIL 2017 criteria
i. All patients must have at least one site of measurable disease as defined by RECIST v. 1.1. or RECIL 2017, for solid tumors and lymphoma, respectively ii. Patients in the expansion cohort must have at least one non-target lesion deemed safe to biopsy, in the opinion of the investigator, and be willing to undergo mandatory core biopsies. This includes pre-treatment and an on-treatment biopsy. Biopsies at the time of progression are highly desired, but optional.
iii. The lesion(s) which will be used for response assessment may not be biopsied iv. Target lesions that have been previously irradiated will not be considered measurable unless increase in size is observed following completion of radiation therapy
All previous therapies of cancer, including radiotherapy major surgery and investigational therapies must be discontinued for ≥14 days (≥ 28 days for mitomycin C or nitrosoureas) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy must have resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v5), except alopecia or parameters defined in this eligibility list.
Age > 18 years.
ECOG performance status 0- 2
Patients must have normal organ and marrow function as defined below
Absolute neutrophil count ≥1,500/mm3 without growth factor use ≤ 7 days prior to C1D1 Platelets ≥85,000/mm3 without platelet transfusion ≤ 7 days prior to C1D1 Hemoglobin >8.5 mg/dL without red blood cell transfusion ≤ 7 days prior to C1D1 Total serum bilirubin <1.5 X upper limit of normal (ULN) (except for patients with documented Gilbert's syndrome) AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if liver dysfunction is felt to be secondary to tumor burden Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2) Serum or urine pregnancy test (WOCBP only) negative ≤7 days of C1D1
Ability to understand and willingness to sign a written informed consent, HIPAA consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lymphoma?

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Approximately 70% of the world's adult population has lymphoma at some point in their life while less than ½ of them are diagnosed with the disease. This disease consists of 5 subtypes: (a) B cell lymphomas, (b) T cell lymphomas, (c) NK cell lymphomas, (c) plasma cell lymphomas and (c) mantle cell lymphomas. Patients of the latter two subtypes are generally at least 60 years of age, males are more often affected than females, and the most common type of lymphomas is the lymphoma not otherwise specified. Lymphomas are quite hard to treat; more than half of them are progressive, do not remit, and rarely respond to treatment.

Unverified Answer

What are the signs of lymphoma?

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The diagnosis of lymphoma is often made when the disease has been present for months and symptoms are unremarkable. The physical signs of lymphoma are non-specific so the diagnosis can delay treatment, especially if lymphoma has spread to the bone marrow. Patients with enlarged lymph nodes may need a test for human immunodeficiency Virus (HIV). The physical signs of Hodgkin's lymphoma include a diffuse bulging neck and upper chest pain. The main physical signs of non-Hodgkin's lymphoma are weight loss and anaemia. A bone scan is useful in confirming the extent and nature of metastasis. Pain is common in lymphoma and can be caused by malignancy.

Unverified Answer

What are common treatments for lymphoma?

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There should be two rounds of therapy with chemotherapy and targeted therapy with immunotherapy in non-Hodgkin lymphoma. In Hodgkin lymphoma, two or three rounds of chemotherapy with radiotherapy and immunotherapy should be the rule in all cases of advanced Hodgkin lymphoma, but in initial and curative types of Hodgkin lymphoma, chemotherapy, including three or more rounds without radiotherapy should be the rule.

Unverified Answer

What causes lymphoma?

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We conclude that the two factors which contribute most substantially to the development of lymphoma were (1) genetic predisposition and (2) environmental factors. The environmental factors acted to make the lymphoma cell more susceptible to the genetic predisposition. Thus, environmental factors, such as radiation, chemical, or viral exposure make the lymphoma cell more susceptible and, in some cases, the environmental factors promote and even cause lymphoma cell to take on the phenotype of a non-lysosomal membrane with antibody proteins attached to them, (‘lymphoma cells in “M” morphology’). In our opinion, it is this phenomenon which gives insight into the immunological processes involved in the development of lymphoma.

Unverified Answer

How many people get lymphoma a year in the United States?

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The cumulative incidence of lymphoma in the US population based on surveillance data is 1.21 per 10,000 population per year, with 2.3 new cases per 10,000 men and 1.7 in women per year. This implies that 1 in 20 men and 1 in 100 women are diagnosed with the disease. If these figures are representative of lymphoma as a whole, lymphoma accounts for more deaths in the US than in any other country. Because of differing incidence of lymphoma between various racial/ethnic groups, further epidemiological studies are needed to determine the contribution of these factors to cancer disparities in the US.

Unverified Answer

Can lymphoma be cured?

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There is debate about the ability of lymphoma treatment to control the emergence of metastatic disease and to prevent cancer recurrence after a remission of the neoplasm. We need prospective randomized trials of the role of treatment strategy for eradicating relapsed disease in patients with high-grade diffuse and aggressive non-Hodgkin's lymphoma. summary: Findings from a recent study presents evidence that lymphoma may not be definitely cured by standard treatments for lymphoma, and that some people might develop a secondary lymphoma after initial remission of lymphoma. The authors discuss this dilemma and encourage the need for clinical trials of new treatment options against lymphoma.

Unverified Answer

Has gamitrinib proven to be more effective than a placebo?

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Gamitrinib has been shown to be as effective as a placebo in a Phase III trial in patients with relapsed, refractory or relapsed acute lymphoblastic leukaemia or B-cell acute lymphoblastic leukaemia. The recommended dose of the drug was well tolerated. Gamitrinib is the first drug to receive U.S. FDA Committee of Review. Additional data will be obtained in the interim of the trial and submitted to FDA, and the Committee's recommendation will be reported at its meeting on 16 February 2017.

Unverified Answer

Have there been any new discoveries for treating lymphoma?

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The current chemotherapy regimen is effective against all types of lymphoma. The advent of the B-lymphocyte-specific CD20-toxin (rituximab) was a major step in the chemotherapy for diffuse large B-cell lymphoma and the antibody therapy, with or without the tyrosine-kinase inhibitor, has been reported to be helpful against T cell acute lymphatic leukemia.. However, in recent years, the research on gene therapy, targeted therapies or immunotherapy for the treatment of lymphoma have been active including gene therapy, targeted therapies or immunotherapy for treating B-cell lymphomas such as FLT3 internal tandem duplication (c.

Unverified Answer

What are the latest developments in gamitrinib for therapeutic use?

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Gamitrinib is a selective, ATP-competitive mTOR inhibitor of the immunosuppressive class. It has single exposures that are not dependent on dosing, and produces robust antitumor effects in mouse models of non-Hodgkin's lymphoma. Results from a recent paper substantiate ongoing development of gamitrinib as a therapeutic for relapsed/refractory malignancies.

Unverified Answer

What is the latest research for lymphoma?

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Lymphogranuloma venereum, Epstein Barr virus and Lymphomatoid granulomatosis are three lymphoma subtypes associated with the use of illicit drugs. In addition there is good evidence for the usefulness of treatment of some B cell chronic lymphoproliferative diseases by rituximab.\n\nThe most common sites of lymphoma are in the lymph organs that collect blood: the spleen, the lymph nodes (especially the central nervous system, bone marrow, and the lymph nodes), and the liver. Most common lymphoma types are diffuse B-cell lymphomas and T-cell lymphomas.

Unverified Answer

What is gamitrinib?

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Gamitrinib is an oral small molecule inhibitor of the protein Aurora-B, which is overexpressed in many cancers and can promote cancer cell growth. Therefore, it appears that Aurora-B is a promising drug target for the treatment of both B-cell and T-cell lymphomas. There is also evidence that in human xenograft tumor models, knockdown of Aurora-B, using small interfering RNA-mediated knockdown, leads to an inhibited growth of many cancer cell types. Thus, Aurora-B might be useful in the treatment of both Hodgkin, and non-Hodgkin lymphoma.

Unverified Answer

How does gamitrinib work?

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Gamitrinib has a broad spectrum of activity in non-Hodgkin’s lymphoma, as demonstrated in both pre-clinical and clinical settings. Gamitrinib is also effective in acute myeloid progenitor cell leukaemia. Further studies to examine the efficacy of gamitrinib against both B- and T-cell lymphomas are warranted.

Unverified Answer
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