Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Prostatic Neoplasms

Lymphoma

Melanoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Lymphosarcoma

Neuroendocrine Tumor

Neuroepithelioma

PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome.

Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). The treatment cycle repeats every 3 weeks for up to 6 cycles in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the study.

PNT2258

Anthony W Tolcher, MD, FRCP(C)

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The purpose of this research study is to evaluate the safety of the investigational drug PNT2258 in patients with advance tumors and see how it acts in the body.

This study is an open-label, single-arm, Phase 1 dose-escalation study of PNT2258 in patients with advanced solid tumors for which no standard therapy exists. Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). At first, patients will be treated in single patient cohorts following an accelerated titration design and evaluated for toxicities. After the accelerated portion ends, patients will be treated in cohorts of at least 3 patients at each dose level and evaluated for treatment-related toxicities.

A Study of PNT2258 in Patients With Advanced Solid Tumors

A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors

Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose

Sierra Oncology LLC - a GSK company

Lymphoma, Non-Hodgkin

PNT2258 120 mg/m2 will be administered as a 2-hour intravenous infusion on days 1-5 of a 21-day cycle. Treatment may continue (unless there is disease progression or the occurrence of unacceptable toxicity) for a total of 6 cycles of therapy.

Barbara Klencke, M.D.

Ayad Al-Katib, MD

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma.

PNT2258 will be administered at a dose of 120 mg/m2, as a 3-hour intravenous (IV) infusion on days 1-5 of a 21-day cycle. Treatment may continue (unless there is disease progression or the occurrence of unacceptable toxicity) for a total of 6 cycles of therapy.

Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Subjects who had a best response of complete response or partial response as assessed by the investigator

The time from Cycle 1 Day 1 until the date of lymphoma progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation

PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.

Age, Categorical

Age, Continuous

Sex: Female, Male

All patients who passed the screening in the study

GSK Response Center

All subjects who received at least 1 dose of PNT2258

Overall Response Rate

Progression-free Survival

Overall Study

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258.

Barbara Klencke, MD

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma.

PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)

A Phase II Study of PNT2258 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

The proportion of patients with complete response (CR/complete metabolic response \[CMR\]) or partial response (PR/partial metabolic response \[PMR\]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)

The proportion of patients who have a response of stable disease (SD/no metabolic response \[NMR\]) or better by investigator assessment

The number of months from Cycle 1 Day 1 until the date of the first documented response

The number of months from C1D1 until the date of DLBCL progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation

Characterization of the type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events, laboratory abnormalities, serious adverse events or adverse events leading to discontinuation of study treatment

The number of months from C1D1 until the date of death from any cause, or to the last date at which survival status was adequately assessed for censored observations

The time from the initial CMR or PMR until the date of progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observations

Adverse events were collected until 30 days after the last dose of PNT2258 for each subject

PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of PNT2258 in Patients With Advanced Solid Tumors	NCT01191775	Cancer Lymphoma Prostate Cancer Melanoma	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company
Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma	NCT01733238	Lymphoma, Non-H...	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company
Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma	NCT01733238	Lymphoma, Non-H...	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company
PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)	NCT02226965	Lymphoma, Diffu...	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company
Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma	NCT01733238	Lymphoma, Non-H...	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company
A Study of PNT2258 in Patients With Advanced Solid Tumors	NCT01191775	Cancer Lymphoma Prostate Cancer Melanoma	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company

Spots Global Cancer Trial Database for pnt2258

Every month we try and update this database with for pnt2258 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 pnt2258

Every month we try and update this database with for pnt2258 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 pnt2258 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.