Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1202-2144 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effect of multiple-dose administration of rifampin on the single dose PK of pevonedistat in adult participants with advanced solid tumors.
The study will enroll approximately 20 participants. The study will be conducted in two Parts: Part A and optional Part B. Part A will have a drug-drug interaction (DDI) assessment. In Part A, participants will be assigned to:
• Pevonedistat 50 mg/m^2 + Rifampin
Eligible participants from Part A will continue treatment in optional Part B with pevonedistat in combination with SoC chemotherapy, docetaxel or carboplatin plus paclitaxel. The investigator will decide which SoC combination partner a participant will receive.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 18 months. Participants will make a final visit to the clinic 30 days after receiving their last dose of study drug or before the start of subsequent therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg | Experimental | Pevonedistat 50 milligram per square meter (mg/m^2), intravenous infusion, once on Day 1 and 10 along with rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. After completion of Part A, participants had opportunity to continue into optional Part B. |
|
| Part B: Pevonedistat | Experimental | Pevonedistat 25 mg/m^2 intravenously in combination with docetaxel 75 mg/m^2 or at 20 mg/m^2 in combination with carboplatin +paclitaxel 175 mg/m^2; pevonedistat was given in combination on Day 1 and as a single agent on Days 3 and 5 of each 21-day cycle. Participants were treated for up to 12 cycles or symptomatic deterioration or PD, treatment was discontinued for another reason, or until the study is stopped in Part B. The choice of combination partner (docetaxel or carboplatin + paclitaxel) was based on investigator discretion. If the sponsor and investigator determine that a participant would derive clinical benefit from continued treatment, the participant may remain on the current combination therapy or receive pevonedistat as a single agent beyond 12 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pevonedistat | Drug | Pevonedistat intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The Least square (LS) means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model. | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model. | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model. | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Total Clearance After Intravenous Administration (CL) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| Part A: Volume of Distribution at Steady State After Intravenous Administration (Vss) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Criteria for Continuation into Optional Part B:
To be eligible for Part B, participants must have completed Part A and be reassessed to determine if they meet the continuation criteria for Part B.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30308 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35932388 | Derived | Zhou X, Vaishampayan U, Mahalingam D, Harvey RD, Chung KY, Sedarati F, Dong C, Faller DV, Venkatakrishnan K, Gupta N. Phase 1 study to evaluate the effects of rifampin on pharmacokinetics of pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):1042-1050. doi: 10.1007/s10637-022-01286-8. Epub 2022 Aug 6. |
Not provided
Not provided
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumor were enrolled in this 2-part study to receive intravenous infusion of pevonedistat along with rifampin capsule in Part A and pevonedistat in combination with chemotherapy agents in Part B (optional part). After completion of Part A, participants had an opportunity to continue into optional Part B.
Participants took part in the study at 4 investigative sites in the United States from 13 August 2018 to 28 February 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg | Pevonedistat 50 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1 and 10, and then rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
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 4, 2018 | Feb 25, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rifampin | Drug | Rifampin capsules. |
|
| Docetaxel | Drug | Docetaxel intravenous infusion. |
|
| Carboplatin | Drug | Carboplatin intravenous infusion. |
|
| Paclitaxel | Drug | Paclitaxel intravenous infusion. |
|
| Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Part A: Terminal Disposition Phase Half-life (T1/2z) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment | Best overall response was defined as participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target and non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: at least 30 percent (%) decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameter. PD: at least 20% increase in sum of diameter of target lesions, taking as reference, smallest sum on study. | Up to Cycle 17 (end of treatment) (Cycle length =21 days) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-2013 | United States |
| Greenville Health System - Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | United States |
| Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2 |
Pevonedistat 25 mg/m^2, infusion, intravenously in combination with docetaxel 75 mg/m^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B. |
| FG002 | Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2 | Pevonedistat 20 mg/m^2, infusion, intravenously in combination with carboplatin area under the plasma concentration (AUC) at the dose of 5 milligram* minute per milliliter (mg*min/mL), infusion, intravenously and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B |
|
The safety analysis set for Part A was defined as all enrolled participants who received at least a single pevonedistat dose during Part A.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg | Pevonedistat 50 mg/m^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||||
| Body Surface Area (BSA) | Mean | Standard Deviation | square meter (m^2) |
|
| 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 | Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The Least square (LS) means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model. | The pharmacokinetic (PK) evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | ratio | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
|
| |||||||||||||||||||||||||
| Primary | Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model. | The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | ratio | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
| ||||||||||||||||||||||||||
| Primary | Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model. | The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | ratio | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
| ||||||||||||||||||||||||||
| Secondary | Part A: Total Clearance After Intravenous Administration (CL) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here number analyzed "n" signifies participants who were evaluable for this outcome measure at given time points. | Posted | Mean | Standard Deviation | liter per hour (L/h) | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Secondary | Part A: Volume of Distribution at Steady State After Intravenous Administration (Vss) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here number analyzed "n" signifies participants who were evaluable for this outcome measure at given time points. | Posted | Mean | Standard Deviation | liter | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Secondary | Part A: Terminal Disposition Phase Half-life (T1/2z) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) | The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here number analyzed "n" signifies participants who were evaluable for this outcome measure at given time points. | Posted | Mean | Standard Deviation | hour | Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Secondary | Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment | Best overall response was defined as participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target and non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: at least 30 percent (%) decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameter. PD: at least 20% increase in sum of diameter of target lesions, taking as reference, smallest sum on study. | The response-evaluable population was defined as all participants who received at least 1 dose of study drug in Part B, had measurable disease as entry criteria for Part B, and had at least 1 postbaseline disease assessment. As planned, this outcome measure was only assessed in Part B. | Posted | Count of Participants | Participants | Up to Cycle 17 (end of treatment) (Cycle length =21 days) |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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 | Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg | Pevonedistat 50 mg/m^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9. | 1 | 20 | 3 | 20 | 11 | 20 |
| EG001 | Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2 | Pevonedistat 25 mg/m^2, infusion, intravenously in combination with docetaxel 75 mg/m^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B. | 0 | 9 | 3 | 9 | 9 | 9 |
| EG002 | Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2 | Pevonedistat 20 mg/m^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg*min/mL, infusion, intravenously and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B. | 1 | 8 | 4 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA23.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA23.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA23.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Medical device site oedema | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA23.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA23.0 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2019 | Feb 25, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| C539933 | pevonedistat |
| D012293 | Rifampin |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
| OG001 | Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2 | Pevonedistat 20 mg/m^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg*min/mL, infusion, intravenously and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B. |
|
|