Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004938-41 | EudraCT Number |
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The decision to discontinue the study was made based on the totality of the clinical, pharmacokinetic, and pharmacodynamic findings. No safety concerns were observed.
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For Phase 1a Part A, the primary objectives are to assess safety and tolerability and to define the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of dalutrafusp alfa (formerly GS-1423) monotherapy in participants with advanced solid tumors.
For Phase 1a Part B, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.
For Phase 1b Cohort 1 safety run-in, the primary objective is to assess safety and tolerability and to define the DLT and MTD or RP2D of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma.
For Phase 1b Cohort 1 post safety run-in, the primary objective is to assess the preliminary efficacy of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma, as assessed by the confirmed objective response rate (ORR).
For Phase 1b Cohort 2, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a, Part A - Dose Escalation | Experimental | Part A will consist of dose escalation by an accelerated dosing design and a 3+3 dose escalation scheme. Participants will receive escalating dose levels dalutrafusp alfa of up to 45 mg/kg on Day 1 of each 2-week cycle (Q2W) until the participant meets study treatment discontinuation criteria or for up to 1 year. |
|
| Phase 1a, Part B - Flat Dose Regimen | Experimental | Part B will consist of 3 adaptive cohorts. Based on PK, pharmacodynamics, and safety results from the Part A study, participants will be administered a flat dose of dalutrafusp alfa on Day 1 of each cycle QW, Q2W and/or every 3 weeks (Q3W) until the participant meets study treatment discontinuation criteria or for up to 1 year. |
|
| Phase 1b, Cohort 1 (Gastric Cancer) | Experimental | Safety run-in: A standard 3+3 dose escalation design will be used to determine the DLT and MTD or RP2D of dalutrafusp alfa in combination with mFOLFOX6. The planned starting dose of dalutrafusp alfa will be targeted to achieve the exposure at -1 dose of RP2D monotherapy (Q2W) determined from Phase 1a. Dalutrafusp alfa will be administered in combination with mFOLFOX6. Post safety run-in: Approximately 70 participants will be enrolled to receive dalutrafusp alfa at the dose level determined from the safety run-in period, in combination with mFOLFOX6 regimen. Participants will receive dalutrafusp alfa on Day 1 of each 14-day cycle up to 2 years until PD, or unacceptable toxicity, substantial noncompliance with study procedures or study drug, study discontinuation or withdrawal from study. Participants will also receive mFOLFOX6 regimen Q2W for up to 12 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalutrafusp alfa | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) | DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient [≤ 3 days] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or > 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death). | Baseline up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant administered the study drug, which did not necessarily have a causal relationship with the treatment. An AE could therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Adverse events might also include pretreatment or posttreatment complications that occurred as a result of protocol-specified procedures or special situations. Preexisting events that increased in severity or change in nature during or as a consequence of participation in the study were also considered AEs. TEAEs were AEs with onset dates on or after the first dose of study drug GS-1423 and up to 30 days after permanent withdrawal of GS-1423. |
Not provided
Key Inclusion Criteria:
Diagnosis:
Measurable disease: Have measurable disease on imaging based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare Hospitals d/b/a HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36746510 | Background | Tolcher AW, Gordon M, Mahoney KM, Seto A, Zavodovskaya M, Hsueh CH, Zhai S, Tarnowski T, Jurgensmeier JM, Stinson S, Othman AA, Chen T, Strauss J. Phase 1 first-in-human study of dalutrafusp alfa, an anti-CD73-TGF-beta-trap bifunctional antibody, in patients with advanced solid tumors. J Immunother Cancer. 2023 Feb;11(2):e005267. doi: 10.1136/jitc-2022-005267. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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The study was discontinued prior to initiation of Phase 1a Part B and Phase 1b. Therefore, data are reported for only Phase 1a Part A.
Participants were enrolled at study sites in United States. The first participant was screened on 03 June 2019. The last study visit occurred on 15 April 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | GS-1423 0.3 mg/kg of body weight, solution for intravenous (IV) infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| FG001 | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| FG002 | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| FG003 | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| FG004 | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| FG005 | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| FG006 | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| BG001 | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) | DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient [≤ 3 days] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or > 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death). | The DLT-Evaluable Analysis Set included all participants who were enrolled for dose escalation, received the protocol-specified treatment, and completed safety procedures through Day 28 (inclusive) or experienced a DLT prior to Day 28. | Posted | Number | percentage of participants | Baseline up to 28 days |
Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
Because the study was terminated after enrolling only 22 participants in the dose-escalation stage (Phase 1a Part A), planned analysis was not conducted for Phase 1a Part B, and Phase 1b.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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 | Apr 29, 2020 | Jul 25, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2021 | Jul 25, 2022 | SAP_001.pdf |
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| Phase 1b, Cohort 2 (Paired Biopsy) | Experimental | Participants will receive dalutrafusp alfa at the dose level determined from Phase 1a Q2W until the participants meets study treatment discontinuation criteria or for up to 1 year. |
|
|
| mFOLFOX6 Regimen | Drug | Chemotherapy regimen of oxaliplatin, 5-fluorouracil [5-FU], and leucovorin |
|
| Dalutrafusp alfa | Drug | Administered intravenously |
|
|
| First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days |
| Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities | Severity was graded per NCI CTCAE v5.0. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death related to AE. | First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days |
| Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study | The Baseline value was the last available value collected on or prior to first dose of study drug. Percentages were based on participants with values available at both baseline and postbaseline. NCS = Non-clinical significance; CS = Clinical significance. | First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days |
| Phase 1a Part A: Pharmacokinetic (PK) Parameter: AUCtau of GS-1423 | AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Cycle 1 and Cycle 4: Day 1 (Predose, end of infusion, 2 and 6 hours post start of infusion); Days 2, 3, 5, and 8 (additionally at Day 15 in Cycle 4) |
| Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) | Baseline, during the treatment (maximum duration: 26.3 weeks), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 6 Day 1, 30-day follow-up (30 days after discontinuation of GS-1423), post treatment follow-up (3 months) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| Withdrew Consent |
|
| Lost to Follow-up |
|
| Study Terminated by Sponsor |
|
| Enrolled but not Treated |
|
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| BG002 | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| BG003 | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| BG004 | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| BG005 | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| BG006 | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
|
|
|
| Secondary | Phase 1a Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant administered the study drug, which did not necessarily have a causal relationship with the treatment. An AE could therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Adverse events might also include pretreatment or posttreatment complications that occurred as a result of protocol-specified procedures or special situations. Preexisting events that increased in severity or change in nature during or as a consequence of participation in the study were also considered AEs. TEAEs were AEs with onset dates on or after the first dose of study drug GS-1423 and up to 30 days after permanent withdrawal of GS-1423. | The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days |
|
|
|
| Secondary | Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities | Severity was graded per NCI CTCAE v5.0. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death related to AE. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days |
|
|
|
| Secondary | Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study | The Baseline value was the last available value collected on or prior to first dose of study drug. Percentages were based on participants with values available at both baseline and postbaseline. NCS = Non-clinical significance; CS = Clinical significance. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days |
|
|
|
| Secondary | Phase 1a Part A: Pharmacokinetic (PK) Parameter: AUCtau of GS-1423 | AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Participants in the PK Analysis Set (all enrolled participants who received at least 1 dose of study drug and had at least 1 non-missing postdose concentration value reported by the PK laboratory) with available data were analyzed. | Posted | Mean | Standard Deviation | µg*h/mL | Cycle 1 and Cycle 4: Day 1 (Predose, end of infusion, 2 and 6 hours post start of infusion); Days 2, 3, 5, and 8 (additionally at Day 15 in Cycle 4) |
|
|
|
| Secondary | Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) | The Immunogenicity Analysis Set included all participants in the Safety Analysis Set who have at least 1 nonmissing postdose ADA status reported. | Posted | Number | percentage of participants | Baseline, during the treatment (maximum duration: 26.3 weeks), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 6 Day 1, 30-day follow-up (30 days after discontinuation of GS-1423), post treatment follow-up (3 months) |
|
|
|
| 1 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG002 | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. | 1 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. | 3 | 3 | 2 | 3 | 3 | 3 |
| EG004 | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. | 2 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. | 2 | 8 | 4 | 7 | 7 | 7 |
| EG006 | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year. | 0 | 3 | 0 | 3 | 3 | 3 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Covid-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic embolus | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Exophthalmos | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to eye | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Serum Chemistry |
|
| Coagulation |
|
| Endocrine Function Tests |
|
| Urinalysis |
|
| Normal baseline - Abnormal NCS |
|
| Normal baseline - Abnormal CS |
|
| Abnormal NCS Baseline - Normal |
|
| Abnormal NCS Baseline - Abnormal NCS |
|
| Abnormal NCS Baseline - Abnormal CS |
|
| Abnormal CS Baseline - Normal |
|
| Abnormal CS Baseline - Abnormal NCS |
|
| Abnormal CS Baseline - Abnormal CS |
|
|
| Cycle 4 |
|
|
| During the Treatment |
|
| Cycle 2 Day 1 |
|
| Cycle 3 Day 1 |
|
| Cycle 4 Day 1 |
|
| Cycle 4 Day 15 |
|
| Cycle 6 Day 1 |
|
| 30-Day Follow-Up |
|
| Post Treatment Follow-Up (3 months) |
|