Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma
This is an open-label, multicenter Phase 1b/2 study evaluating nanatinostat in combination with valganciclovir alone and in combination with pembrolizumab. Nanatinostat is a selective class I HDAC inhibitor which induces EBV early lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form.
The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) in patients with EBV+ RM-NPC followed by a Project Optimus | FDA (https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus) cohort to confirm the RP2D. Up to 60 patients with EBV+ RM-NPC will be randomized 1:1 to receive nanatinostat in combination with valganciclovir at the confirmed RP2D with or without pembrolizumab to evaluate safety, overall response rate, and potential pharmacodynamic markers in the Phase 2 dose expansion part of the study. Additionally, patients with other EBV+ solid tumors will be enrolled to receive nanatinostat in combination with valganciclovir at the RP2D in a Phase 1b cohort.
The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanatinostat in combination with valganciclovir | Experimental | Phase 1b: Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week, and valganciclovir starting at 900 mg orally daily, then Phase 2: Nanatinostat and valganciclovir at the confirmed recommended Phase 2 dose |
|
| Nanatinostat in combination with valganciclovir and pembrolizumab | Experimental | Phase 2: Nanatinostat and valganciclovir at the confirmed recommended Phase 2 doses in combination with pembrolizumab 200 mg intravenous (IV) every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanatinostat | Drug | Phase 1b: Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week, then Phase 2: Nanatinostat at the confirmed recommended Phase 2 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Incidence of Dose-Limiting Toxicities (DLTs) | Percentage of patients experiencing a DLT, defined as an adverse event or clinically significant abnormal laboratory value that is at least possibly related to study drugs and is not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness | DLT period of 28 days |
| Phase 2: Overall Response Rate (ORR) | Percentage of patients with a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1) | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Percentage of patients experiencing at least one treatment-emergent adverse event (AE), defined as those AEs with onset after the first dose of study drug or existing events that worsened after the first dose during the study | Approximately 3 years |
| Phase 2: Duration of Response (DOR) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darrel P Cohen, MD, PhD | Viracta Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94305 | United States | ||
| University of Colorado Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dose Cohort 1 | Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily |
| FG001 | Dose Cohort 2 | Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2023 | Jan 27, 2025 |
Not provided
A traditional 3+3 dose escalation design followed first by a dose optimization cohort and then by dose expansion with 1:1 randomization to receive nanatinostat and valganciclovir with or without pembrolizumab in Phase 2.
The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.
Not provided
Not provided
Not provided
Not provided
|
| Valganciclovir | Drug | Phase 1b: Valganciclovir starting at 900 mg orally daily, then Phase 2: Valganciclovir at the confirmed recommended Phase 2 dose |
|
|
| Pembrolizumab | Drug | Phase 2: Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks |
|
|
Interval of time from the date of first observed CR or PR to the date of documented disease progression or death due to any cause, whichever occurs first |
| Approximately 3 years |
| Phase 2: Disease Control Rate (DCR) | Percentage of patients having a CR, PR, or stable disease at any time during treatment | Approximately 3 years |
| Phase 2: Progression-Free Survival (PFS) | Interval of time from the start of study drug treatment to the date of first documented disease progression or death from any cause, whichever occurs first | Approximately 3 years |
| Phase 2: Overall Survival (OS) | Interval of time from the start of study drug treatment to date of death for any reason | Approximately 3 years |
| Pharmacokinetic Parameter (Nanatinostat) - Time to Maximum Plasma Concentration [Tmax] | Defined as the time required to reach peak plasma concentration [Cmax] after nanatinostat administration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Pharmacokinetic Parameter (Ganciclovir) - Time to Maximum Plasma Concentration [Tmax] | Defined as the time required to reach peak plasma concentration [Cmax] after valganciclovir administration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Pharmacokinetic Parameter (Nanatinostat) - Maximum Plasma Concentration [Cmax] | Defined as the peak plasma concentration [Cmax] after nanatinostat administration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Pharmacokinetic Parameter (Ganciclovir) - Maximum Plasma Concentration [Cmax] | Defined as the peak plasma concentration [Cmax] after valganciclovir administration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Pharmacokinetic Parameter (Nanatinostat) - Area Under the Plasma Concentration-Time Curve [AUC0-t] | Defined as the area under the concentration-time curve from time 0 to the last measurable nanatinostat concentration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Pharmacokinetic Parameter (Ganciclovir) - Area Under the Plasma Concentration-Time Curve [AUC0-t] | Defined as the area under the concentration-time curve from time 0 to the last measurable ganciclovir concentration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Pharmacokinetic Parameter (Nanatinostat) - Half-Life of Nanatinostat [t1/2] | Defined as the time required to reduce nanatinostat plasma concentration by 50% after nanatinostat administration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Pharmacokinetic Parameter (Ganciclovir) - Half-Life of Ganciclovir [t1/2] | Defined as the time required to reduce ganciclovir plasma concentration by 50% after valganciclovir administration on Cycle 2 Day 1 | Approximately 28 days following enrollment |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Blacktown Hospital | Blacktown | Australia |
| Princess Margaret Cancer Centre | Toronto | Canada |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Prince Of Wales Hospital, The Chinese University Of Hong Kong | Shatin | Hong Kong |
| Sarawak General Hospital | Kuching | Sarawak | Malaysia |
| University of Malaya Medical Centre | Kuala Lumpur | Malaysia |
| National Cancer Centre Singapore | Singapore | Singapore |
| Samsung Medical Center | Seoul | South Korea |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan City | Taiwan |
| FG002 | Dose Cohort 3 | Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily |
| FG003 | Dose Cohort 4 | Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| FG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| FG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| FG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Cohort 1 | Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily |
| BG001 | Dose Cohort 2 | Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily |
| BG002 | Dose Cohort 3 | Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily |
| BG003 | Dose Cohort 4 | Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| BG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| BG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| BG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Tumor Type | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1b: Incidence of Dose-Limiting Toxicities (DLTs) | Percentage of patients experiencing a DLT, defined as an adverse event or clinically significant abnormal laboratory value that is at least possibly related to study drugs and is not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness | Phase 1b safety analysis population, defined as all patients with recurrent or metastatic EBV+ nasopharyngeal carcinoma who received at least one dose of study treatment in Phase 1b | Posted | Count of Participants | Participants | DLT period of 28 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 2: Overall Response Rate (ORR) | Percentage of patients with a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1) | The clinical trial was terminated before participants were enrolled in Phase 2 | Posted | Approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events | Percentage of patients experiencing at least one treatment-emergent adverse event (AE), defined as those AEs with onset after the first dose of study drug or existing events that worsened after the first dose during the study | Safety analysis population, defined as all patients who received at least one dose of study treatment | Posted | Count of Participants | Participants | Approximately 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Duration of Response (DOR) | Interval of time from the date of first observed CR or PR to the date of documented disease progression or death due to any cause, whichever occurs first | The clinical trial was terminated before participants were enrolled in Phase 2 | Posted | Approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Disease Control Rate (DCR) | Percentage of patients having a CR, PR, or stable disease at any time during treatment | The clinical trial was terminated before participants were enrolled in Phase 2 | Posted | Approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Progression-Free Survival (PFS) | Interval of time from the start of study drug treatment to the date of first documented disease progression or death from any cause, whichever occurs first | The clinical trial was terminated before participants were enrolled in Phase 2 | Posted | Approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Overall Survival (OS) | Interval of time from the start of study drug treatment to date of death for any reason | The clinical trial was terminated before participants were enrolled in Phase 2 | Posted | Approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Nanatinostat) - Time to Maximum Plasma Concentration [Tmax] | Defined as the time required to reach peak plasma concentration [Cmax] after nanatinostat administration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Median | Full Range | hours | Approximately 28 days following enrollment |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Ganciclovir) - Time to Maximum Plasma Concentration [Tmax] | Defined as the time required to reach peak plasma concentration [Cmax] after valganciclovir administration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Median | Full Range | hours | Approximately 28 days following enrollment |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Nanatinostat) - Maximum Plasma Concentration [Cmax] | Defined as the peak plasma concentration [Cmax] after nanatinostat administration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Approximately 28 days following enrollment |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Ganciclovir) - Maximum Plasma Concentration [Cmax] | Defined as the peak plasma concentration [Cmax] after valganciclovir administration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Approximately 28 days following enrollment |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Nanatinostat) - Area Under the Plasma Concentration-Time Curve [AUC0-t] | Defined as the area under the concentration-time curve from time 0 to the last measurable nanatinostat concentration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Approximately 28 days following enrollment |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Ganciclovir) - Area Under the Plasma Concentration-Time Curve [AUC0-t] | Defined as the area under the concentration-time curve from time 0 to the last measurable ganciclovir concentration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Approximately 28 days following enrollment |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Nanatinostat) - Half-Life of Nanatinostat [t1/2] | Defined as the time required to reduce nanatinostat plasma concentration by 50% after nanatinostat administration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Mean | Standard Deviation | hours | Approximately 28 days following enrollment |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter (Ganciclovir) - Half-Life of Ganciclovir [t1/2] | Defined as the time required to reduce ganciclovir plasma concentration by 50% after valganciclovir administration on Cycle 2 Day 1 | PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7. | Posted | Mean | Standard Deviation | hours | Approximately 28 days following enrollment |
|
Approximately 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Cohort 1 | Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Dose Cohort 2 | Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily | 0 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Dose Cohort 3 | Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily | 1 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Dose Cohort 4 | Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily | 0 | 4 | 2 | 4 | 4 | 4 |
| EG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily | 0 | 3 | 3 | 3 | 3 | 3 |
| EG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily | 0 | 6 | 6 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatinine increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Contusion | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darrel Cohen | Viracta Therapeutics | 858-400-8470 | ClinicalTrials@Viracta.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2024 | Jan 27, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other EBV+ Cancer |
|
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
| OG004 | Dose Cohort 5 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily |
| OG005 | Dose Cohort 6 | Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
| OG006 | Dose Cohort 7 | Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily |
|
|