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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1223-2659 | Other Identifier | WHO | |
| jRCT2080224519 | Registry Identifier | jRCT |
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This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of the study.
The main aim of the 1st part of the study is to check how much Mobocertinib adults with non-small cell lung cancer (NSCLC) can receive without getting side effects from it.
The main aim of the 2nd part of the study is to learn if the condition of adults with non-small cell lung cancer improves after treatment with Mobocertinib. Another aim is to continue checking for side effects from Mobocertinib.
In the 1st part of the study, at the first visit, the study doctor will check who can take part. For those that can take part, participants will take a capsule of Mobocertinib once a day for 28 days. This will count as 1 cycle. Different small groups of participants will receive lower to higher doses of Mobocertinib. The study doctors will check for side effects after each dose of TAK 788. In this way, researchers can work out the best dose of Mobocertinib to give participants in the 2nd part of the study.
Participants will visit the clinic 30 days after their treatment has finished for a final check-up.
In the 2nd part of the study, at the first visit, the study doctor will check who can take part. Participants will receive the best dose of Mobocertinib worked out from the 1st part of the study. Participants will receive Mobocertinib in the same way as those from the 1st part of the study. The study doctors will learn if the condition of these participants improves after treatment with Mobocertinib. The study doctors will also check for side effects from Mobocertinib.
After treatment has finished, participants will visit the clinic every 12 weeks until the end of the study.
In both parts of the study, participants can receive Mobocertinib for up to just over 1 year, or longer if their condition stays improved.
The drug being tested in this study is called Mobocertinib. Mobocertinib is being tested to treat Japanese participants with NSCLC. This study has two parts (Phase 1 part and Phase 2 part), Phase 1 part of this study will look at the safety, efficacy, tolerability and PK of Mobocertinib orally administered once daily, and will determine a RP2D. Phase 2 study will look at the efficacy and safety of Mobocertinib in treatment naive Japanese NSCLC patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation. All participants will be assigned to Phase 1 part or Phase 2 part and will be asked to take Mobocertinib capsule as following dosage and regimen;
Phase 1 part; Mobocertinib, 40 mg as starting dose, once daily, and escalating up to 160 mg until a Maximum Tolerated Dose (MTD). An expansion phase may be followed at any dose to further confirm safety observations following identification of MTD/RP2D.
Phase 2 part; Mobocertinib, 160 mg, once daily
The study will enroll approximately 58-63 participants (Phase 1 part; 28-33 and Phase 2 part; 30).
This multi-center trial will be conducted in Japan. The overall time to participate in this study of Phase 1 part is approximately 3 years and Phase 2 part is approximately 4 years. Participants will make multiple visits to the clinic in the treatment period, and the post-treatment period including follow-up assessments after the last dose of the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobocertinib, Phase 1 Part | Experimental | Mobocertinib 40 milligrams (mg) (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle for up to disease progression or intolerable toxicity, or another discontinuation criterion, and increasing until 160 mg, once daily (for up to approximately 10-12 cycles). |
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| Mobocertinib, Phase 2 Part | Experimental | Mobocertinib 160 mg, once daily, for up to approximately 10-12 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobocertinib | Drug | Mobocertinib capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Part: Recommended Phase 2 Dose (RP2D) of Orally Administered Mobocertinib | The RP2D was the maximum tolerated dose (MTD) or less. The MTD was declared when at least 9 participants were evaluable in the study and 6 participants were evaluable at the current dose, and the current dose was recommended for the next cohort. The dose recommended for use in phase 2 part was analyzed on the basis of the safety and tolerability data obtained in phase 1 part of the study. | Cycle 1 (Cycle length=28 days) |
| Phase 2 Part: Confirmed Objective Response Rate (ORR) as Assessed by the Independent Review Committee (IRC) | Confirmed ORR is defined as percentage of participants who were confirmed to had achieved complete response (CR) or partial response (PR) per IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 millimeter (mm) in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in sum of the longest diameters (SLD) of target lesions, taking as reference baseline sum diameters. The SLD must also demonstrate an absolute increase of at least 5 mm. | From the first dose of the study drug until progressive disease (PD) (up to 2 years and 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug until 30 days after the last dose or before initiation of new anticancer therapy (whichever comes first) (Up to 2 years and 9 months, till data cut-off of 08 November 2021) | |
| Phase 1 Part: Number of Participants With First Cycle DLTs Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.00 |
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Inclusion Criteria:
General Inclusion Criteria (Both in Phase 1 and Phase 2 Part);
Male or female patients ≥20 years old.
Must have measurable disease by RECIST v1.1. Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Minimum life expectancy of 3 months or more.
Adequate renal and hepatic function as defined by the following criteria:
•Total serum bilirubin ≤1.5 × upper limit of normal (ULN) (≤3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy);
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (or ≤5 × ULN if liver function abnormalities are due to underlying malignancy);
•Estimated creatinine clearance ≥30 mL/min (calculated by using the Cockcroft-Gault equation);
•Serum albumin ≥2 g/dL; and
•Serum lipase ≤1.5 × ULN; and
•Serum amylase ≤1.5 × ULN unless the increased serum amylase is due to salivary isoenzymes.
Adequate bone marrow function as defined by the following criteria:
Normal QT interval on screening ECG, defined as QTcF of ≤450 ms in males or ≤470 ms in females.
Female patients who:
Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
Male patients, even if surgically sterilized (ie, status postvasectomy), who:
Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
9.Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
10.Willingness and ability to comply with scheduled visits and study procedures.
Phase-Specific Inclusion Criteria (Phase 1 part);
1.Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) (Stage IIIB) or metastatic NSCLC (Stage IV).
2.Refractory to standard available therapies. 3.All toxicities from prior therapy have resolved to ≤ grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or have resolved to baseline, at the time of first dose of Mobocertinib. Note: treatment-related grade >1 alopecia or treatment-related grade 2 peripheral neuropathy are allowed if deemed irreversible.
Phase-Specific Inclusion Criteria (Phase 2 part);
Histologically or cytologically confirmed locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.
Not received prior systemic treatment for locally advanced or metastatic disease (with the exception below): Neoadjuvant or adjuvant chemotherapy/immunotherapy for Stage I to III or combined modality chemotherapy/radiation for locally advanced disease is allowed if completed >6 months before the development of metastatic disease.
A documented EGFR in-frame exon 20 insertion (including A763_Y764insFQEA, V769_D770insASV, D770_N771insNPG, D770_N771insSVD, H773_V774insNPH, or any other in-frame exon 20 insertion mutation) by a local test that has been analytically validated per local authority guidelines. The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations except EGFR common mutations (exon 19 del or L858R).
Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR in-frame exon 20 insertion mutation. Note: confirmation of central test positivity is not required before the first dose of Mobocertinib.
Exclusion Criteria:
General Exclusion Criteria (Both in Phase 1 and Phase 2 Part);
Myocardial infarction within 6 months prior to the first dose of study drug;
Unstable angina within 6 months prior to first dose;
Congestive heart failure within 6 months prior to first dose;
History of clinically significant (as determined by the treating physician) atrial arrhythmia;
Any history of ventricular arrhythmia; or
Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose.
5.Have uncontrolled hypertension. Patients with hypertension should be under treatment on study entry to control blood pressure.
6.Currently being treated with medications known to be associated with the development of Torsades de Pointes.
7.Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics. Have a known history of HIV infection. Testing of HIV is not required in the absence of history.Hepatitis B surface antigen (HBsAg) positive patients are allowed to enroll if hepatitis B virus (HBV)-DNA is below 1000 copies/mL in the plasma.Patients who have positive hepatitis C virus (HCV) antibody can be enrolled but must have HCV-RNA undetectable in the plasma.
8.Currently have or have a history of interstitial lung disease (ILD), radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
9.Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.
Note: Female patients who are lactating will be eligible if they discontinue breastfeeding.
10.Have gastrointestinal illness or disorder that could affect oral absorption of Mobocertinib.
11.Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.
Phase-Specific Exclusion Criteria (Phase 1 part);
Previously received Mobocertinib.
Received small-molecule anticancer therapy (including cytotoxic chemotherapy and investigational agents) within 14 days prior to the first dose of Mobocertinib (except for reversible EGFR TKIs [ie, erlotinib or gefitinib] up to 7 days prior to the first dose of Mobocertinib).
Received antineoplastic monoclonal antibodies including immunotherapy within 28 days prior to the first dose of Mobocertinib.
Received radiotherapy within 14 days prior to the first dose of Mobocertinib, Stereotactic radiosurgery (SRS) and stereotactic body radiosurgery are allowed up to 7 days prior to the first dose.
Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring corticosteroids to control symptoms within 7 days prior to the first dose of Mobocertinib.
Note: If a patient has worsening neurological symptoms or signs due to CNS metastases, the patient needs to complete local therapy and be neurologically stable (with no requirement for corticosteroids or use of anticonvulsants) for 7 days prior to the first dose of Mobocertinib. Patients with no prior history of signs or symptoms of CNS metastases but who receive prophylactic steroids or anticonvulsants are allowed.
Received a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer within 2 weeks prior to first dose of Mobocertinib.
Phase-Specific Exclusion Criteria (Phase 2 part);
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | Japan | |||
| Fujita Health University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36537204 | Derived | Yang JC, Zhou C, Janne PA, Ramalingam SS, Kim TM, Riely GJ, Spira AI, Piotrowska Z, Mekhail T, Garcia Campelo MR, Felip E, Bazhenova L, Jin S, Kaur M, Diderichsen PM, Gupta N, Bunn V, Lin J, N Churchill E, Mehta M, Nguyen D. Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment for EGFR exon 20 insertion-positive non-small cell lung cancer. Expert Rev Anticancer Ther. 2023 Jan;23(1):95-106. doi: 10.1080/14737140.2023.2157815. Epub 2022 Dec 28. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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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 a diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) were enrolled in a Dose Escalation Phase 1 Part of the study to receive mobocertinib (40, 120 or 160 milligram [mg]) and participants with locally advanced or metastatic NSCLC harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations were enrolled in Phase 2 Part of the study to receive RP2D of mobocertinib confirmed from the Phase 1 Part.
Participants took part in the study at 4 investigative sites for Phase 1 and 17 investigative sites for Phase 2 in Japan from 04 February 2019. The study is currently ongoing. Results in this summary are reported based on the primary completion date (08 November 2021) of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobocertinib 40 mg, Phase 1 Part | Mobocertinib 40 mg (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2022 | Nov 6, 2022 |
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DLT was defined as drug-related toxicity which met one of the following criteria and occurred within the first 28 days of study treatment (Cycle 1): Non-hematologic toxicities any >=grade (G) 3 non-hematologic toxicity, with exception of self-limiting or medically controllable toxicities(nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <3 days, excluding alopecia. Hematologic toxicities: febrile neutropenia not related to underlying disease (fever,>38.3 degree Celsius [C]); absolute neutrophil count <0.5*10^9 per liter [/L]); prolonged G4 neutropenia (>=7 days) (if granulocyte-colony stimulating factor [G-CSF] required, event considered as DLT irrespective of the duration); neutropenic infection:>=G3 neutropenia with >=G3 infection; thrombocytopenia >=G3 with bleeding, >=G3 requiring platelet transfusion or G4 without bleeding lasting >=7 days. Missed >=25% of planned doses of drug over 28 days due to treatment-related AEs in first cycle. |
| Cycle 1 (Cycle length=28 days) |
| Phase 1 Part: Number of DLTs for Mobocertinib Based on NCI CTCAE, Version 5.00 | DLT was defined as drug-related toxicity which met one of the following criteria and occurred within the first 28 days of study treatment (Cycle 1): Non-hematologic toxicities any >=G 3 non-hematologic toxicity, with exception of self-limiting or medically controllable toxicities (nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <3 days, excluding alopecia. Hematologic toxicities: febrile neutropenia not related to underlying disease (fever,>38.3 degree C); absolute neutrophil count <0.5*10^9/L); prolonged G4 neutropenia (>=7 days) (if granulocyte-colony stimulating factor [G-CSF] required, event considered as DLT irrespective of the duration); neutropenic infection: >=G3 neutropenia with >=G3 infection; thrombocytopenia >=G3 with bleeding, >=G3 requiring platelet transfusion or G4 without bleeding lasting >=7 days. Missed >=25% of planned doses of drug over 28 days due to treatment-related AEs in first cycle. | Cycle 1 (Cycle length=28 days) |
| Phase 1 Part: Maximum Tolerated Dose (MTD) of Orally Administered Mobocertinib | The MTD was declared when at least 9 participants were evaluable in the study and 6 participants were evaluable at the current dose, and the current dose was recommended for the next cohort. | Cycle 1 (Cycle length=28 days) |
| Phase 1 Part, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose | Cycle 1 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
| Phase 1 Part, Tmax: Time of First Occurrence of Cmax for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose | Cycle 1 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
| Phase 1 Part, AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose | Cycle 1 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
| Phase 1 Part, Cmax, ss: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
| Phase 1 Part, Tmax, ss: Time of First Occurrence of Cmax for Mobocertinib Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
| Phase 1 Part, AUC24, ss: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
| Phase 1 Part, Rac (AUC 24): Extent of Accumulation Ratio Based on AUC 24 on Multiple Dosing for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | Rac (AUC 24) was calculated as the ratio of drug concentrations observed during a dosing interval at steady state divided by drug concentrations seen during the dosing interval after a single (first) dose. Rac (AUC 24) = AUC(0-24) on Cycle 2 Day 1/ AUC(0-24) on Cycle 1 Day 1. | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
| Phase 1 Part: ORR in Participants With EGFR Mutations as Assessed by Investigator | Investigator assessed ORR using RECIST version 1.1 in participants with EGFR mutations. ORR was defined as the percentage of participants achieving CR and PR per RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. All participants with ORR had documentation of EGFR exon 20 insertion mutation. | From the first dose of the study drug until PD (up to 2 years and 9 months, till data cut-off of 08 November 2021) |
| Phase 1 Part: ORR in Participants With HER2 Mutations as Assessed by Investigator | Investigator assessed ORR using RECIST version 1.1 in participants with HER2 mutations. ORR was defined as the percentage of participants achieving CR and PR per RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. | From the first dose of the study drug until PD (up to 2 years and 9 months, till data cut-off of 08 November 2021) |
| Phase 2 Part: Confirmed ORR as Assessed by the Investigator | Confirmed ORR was defined as the percentage of the participants who were confirmed to have achieved CR or PR per the investigator using RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. | From the first dose of the study drug until PD (up to 2 years and 9 months, till data cut-off of 08 November 2021) |
| Phase 2 Part: Duration of Response (DOR) as Assessed by the IRC as Per RECIST V1.1 | Duration of response as assessed by the IRC was defined as the time interval from first documentation of CR/PR (whichever is first recorded) until the first date that PD is objectively documented. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD. PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest); PD (non-target lesion response): Unequivocal progression of existing non-target lesions. The SLD must also demonstrate an absolute increase of at least 5 mm. | From first documentation of CR/PR until first PD (Up to 2 years and 9 months, till data cut-off of 08 November 2021) |
| Phase 2 Part: DOR as Assessed by Investigator as Per RECIST V1.1 | Duration of response as assessed by the investigator was defined as the time interval from first documentation of CR/PR (whichever is first recorded) until the first date that PD is objectively documented. CR (target lesion response):disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD. PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest); PD (non-target lesion response): Unequivocal progression of existing non-target lesions. The SLD must also demonstrate an absolute increase of at least 5 mm. | From first documentation of CR/PR until first PD (Up to 2 years and 9 months, till data cut-off of 08 November 2021) |
| Phase 2 Part: Time to Response as Assessed by the IRC as Per RECIST V1.1 | Time to response as assessed by the IRC was defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for participants with confirmed CR/PR. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. | From the first dose of the study drug up to first confirmed CR or PR (Up to 2 years 9 months, till data cut-off of 08 November 2021) |
| Phase 2 Part: Time to Response as Assessed by the Investigator Per RECIST V1.1 | Time to response as assessed by the investigator was defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for participants with confirmed CR/PR. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. | From the first dose of the study drug up to first confirmed CR or PR (Up to 2 years 9 months, till data cut-off of 08 November 2021) |
| Phase 2 Part: Disease Control Rate (DCR) as Assessed by the IRC as Per RECIST V1.1 | DCR as assessed by IRC was defined as percentage of participants achieved CR, PR, stable disease (SD) (measurements must had met SD criteria at least once after study entry at minimum interval of 42 days) after initiation of study drug.CR(target lesion): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis.CR(non-target lesion): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level.PR(target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.SD(target lesion): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.PD(target lesion): SLD increased by at least 20% from smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm.PD (non-target lesion): unequivocal progression of existing non-target lesions. | From the first dose of the study drug until PD (Up to 2 years 9 month, till data cut-off of 08 November 2021) |
| Phase 2 Part: DCR as Assessed by the Investigator Per RECIST V1.1 | DCR as assessed by investigator was defined as percentage of participants achieved CR, PR, SD (measurements must had met SD criteria at least once after study entry at minimum interval of 42 days) after initiation of study drug. CR (target lesion): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.SD (target lesion): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD(target lesion): SLD increased by at least 20% from smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm.PD (non-target lesion): unequivocal progression of existing non-target lesions. | From the first dose of the study drug until PD (Up to 2 years 9 month, till data cut-off of 08 November 2021) |
| Phase 2 Part: Progression Free Survival (PFS) as Assessed by the IRC as Per RECIST V1.1 | PFS as assessed by the IRC was defined as the time interval from the start of study treatment until to the first documentation of PD or death due to any cause (whichever comes first) according to RECIST version 1.1.PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. PD (non-target lesion response): unequivocal progression of existing non-target lesions. | From the first dose of the study drug until PD or death due to any cause (whichever comes first) (Up to 2 years and 9 months, till data cut-off of 08 November 2021 |
| Phase 2 Part: PFS as Assessed by the Investigator as Per RECIST V1.1 | PFS as assessed by the investigator was defined as the time interval from the start of study treatment until to the first documentation of PD or death due to any cause (whichever comes first) according to RECIST version 1.1.PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. PD (non-target lesion response): unequivocal progression of existing non-target lesions. | From the first dose of the study drug until PD or death due to any cause (whichever comes first) (Up to 2 years and 9 months, till data cut-off of 08 November 2021 |
| Phase 2 Part: Overall Survival (OS) | OS was defined as the interval from the date of the first dose of the study treatment until death due to any cause. | From the start of the study drug up to death due to any cause (Up to 2 years 9 months, till data cut-off of 08 November 2021) |
| Phase 2 Part: Change From Baseline in Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | EORTC QLQ-C30, version 3.0 was a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); a global health status (GHS)/quality-of-life (QoL) scale; and a six single-item scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores converted into scale scores ranging from 0 to 100. For functional and GHS/QoL scales, higher scores represent better HRQoL (positive change from Baseline=improvement), for symptom scales lower scores represent better QoL (i.e., a low level of symptomatology/problems) (negative change from Baseline=improvement), and for six-single item scale, lower scores represent better HRQoL (negative change from Baseline=improvement). | Baseline and at 30 days after last dose (at Month 19) |
| Phase 2 Part: Change From Baseline in Patient-reported Symptoms (Particular Core Symptoms of Lung Cancer), Functioning, and HRQoL as Assessed by the EORTC Lung Cancer Module QLQ-LC13 | HRQOL scores was assessed with EORTC, it is a lung cancer module QLQ-LC13, version 3.0. QLQ-LC13 included 13 questions (4-point scale where 1=Not at all [best] to 4=Very much [worst]) assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain [chest, arm or shoulder, other parts]), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Subscale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. | Baseline and at 30 days after last dose (at Month 19) |
| Toyoake |
| Aichi-ken |
| Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | Japan |
| Kurume University Hospital | Kurume | Fukuoka | Japan |
| Hokkaido Cancer Center | Sapporo | Hokkaido | Japan |
| Hyogo Cancer Cente | Akashi | Hyōgo | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Japan |
| Sendai Kousei Hospital | Sendai | Miyagi | Japan |
| Okayama University Hospital | Kita-ku | Okayama-ken | Japan |
| Kansai Medical University Hospital | Hirakata | Osaka | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Sakai | Osaka | Japan |
| Kindai University Hospital | Sayama | Osaka | Japan |
| Saitama Cancer Center | Shinden | Saitama | Japan |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Bunkyo-ku | Tokyo | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Japan |
| Cancer Institute Hospital | Koto-ku | Tokyo | Japan |
| Yamaguchi Ube Medical Center | Ube | Yamaguchi | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Hiroshima University Hospital | Hiroshima | Japan |
| Kyoto University Hospital | Kyoto | Japan |
| Niigata Cancer Center Hospital | Niigata | Japan |
| Osaka International Cancer Institute | Osaka | Japan |
| Tokushima University Hospital | Tokushima | Japan |
| Wakayama Medical University Hospital | Wakayama | Japan |
| Mobocertinib 120 mg, Phase 1 Part |
Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| FG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| FG003 | Mobocertinib 160 mg, Phase 2 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. |
| COMPLETED |
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| NOT COMPLETED |
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The safety population included all participants who received at least 1 dose of mobocertinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mobocertinib 40 mg, Phase 1 Part | Mobocertinib 40 mg (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| BG001 | Mobocertinib 120 mg, Phase 1 Part | Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| BG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| BG003 | Mobocertinib 160 mg, Phase 2 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Disease Stage at Screening | Cancer stage is a measure of disease progression. The later stage indicates more advanced cancer. So, the Participants with Stage IV cancer had more advanced disease than stage III participants. The letters represent sub groups within a given stage, with B representing more advanced cancer than A. Other: Unknown or not staged. | Count of Participants | Participants |
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| Time Since Initial Diagnosis | Median | Full Range | months |
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| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | ECOG-PS assessed participant's performance status scale of 0 to 5: 0=Fully active/able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (> [greater than] 50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. A higher score indicated greater functional impairment. | Count of Participants | Participants |
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| Central Nervous System (CNS) involvement at Screening | Count of Participants | Participants |
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| Histopathological Classification of NSCLC | Participants with NSCLC were categorized into adenocarcinoma, adenosquamous carcinoma, large cell, squamous, unknown and other. | Count of Participants | Participants |
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| Smoking History | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||
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| Primary | Phase 1 Part: Recommended Phase 2 Dose (RP2D) of Orally Administered Mobocertinib | The RP2D was the maximum tolerated dose (MTD) or less. The MTD was declared when at least 9 participants were evaluable in the study and 6 participants were evaluable at the current dose, and the current dose was recommended for the next cohort. The dose recommended for use in phase 2 part was analyzed on the basis of the safety and tolerability data obtained in phase 1 part of the study. | The dose-limiting toxicity (DLT)-evaluable population included all participants who received at least 75 percent (%) of their planned mobocertinib doses for their first cycle of treatment (unless interrupted by study drug-related AEs). As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Number | mg | Cycle 1 (Cycle length=28 days) |
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| Primary | Phase 2 Part: Confirmed Objective Response Rate (ORR) as Assessed by the Independent Review Committee (IRC) | Confirmed ORR is defined as percentage of participants who were confirmed to had achieved complete response (CR) or partial response (PR) per IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 millimeter (mm) in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in sum of the longest diameters (SLD) of target lesions, taking as reference baseline sum diameters. The SLD must also demonstrate an absolute increase of at least 5 mm. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of the study drug until progressive disease (PD) (up to 2 years and 9 months) |
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| Secondary | Phase 1 Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | The safety population included all participants who received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Count of Participants | Participants | From first dose of study drug until 30 days after the last dose or before initiation of new anticancer therapy (whichever comes first) (Up to 2 years and 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 1 Part: Number of Participants With First Cycle DLTs Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.00 | DLT was defined as drug-related toxicity which met one of the following criteria and occurred within the first 28 days of study treatment (Cycle 1): Non-hematologic toxicities any >=grade (G) 3 non-hematologic toxicity, with exception of self-limiting or medically controllable toxicities(nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <3 days, excluding alopecia. Hematologic toxicities: febrile neutropenia not related to underlying disease (fever,>38.3 degree Celsius [C]); absolute neutrophil count <0.5*10^9 per liter [/L]); prolonged G4 neutropenia (>=7 days) (if granulocyte-colony stimulating factor [G-CSF] required, event considered as DLT irrespective of the duration); neutropenic infection:>=G3 neutropenia with >=G3 infection; thrombocytopenia >=G3 with bleeding, >=G3 requiring platelet transfusion or G4 without bleeding lasting >=7 days. Missed >=25% of planned doses of drug over 28 days due to treatment-related AEs in first cycle. | The DLT-evaluable population included as all participants who received at least 75% of their planned mobocertinib doses for their first cycle of treatment (unless interrupted by study drug-related AEs). As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Count of Participants | Participants | Cycle 1 (Cycle length=28 days) |
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| Secondary | Phase 1 Part: Number of DLTs for Mobocertinib Based on NCI CTCAE, Version 5.00 | DLT was defined as drug-related toxicity which met one of the following criteria and occurred within the first 28 days of study treatment (Cycle 1): Non-hematologic toxicities any >=G 3 non-hematologic toxicity, with exception of self-limiting or medically controllable toxicities (nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <3 days, excluding alopecia. Hematologic toxicities: febrile neutropenia not related to underlying disease (fever,>38.3 degree C); absolute neutrophil count <0.5*10^9/L); prolonged G4 neutropenia (>=7 days) (if granulocyte-colony stimulating factor [G-CSF] required, event considered as DLT irrespective of the duration); neutropenic infection: >=G3 neutropenia with >=G3 infection; thrombocytopenia >=G3 with bleeding, >=G3 requiring platelet transfusion or G4 without bleeding lasting >=7 days. Missed >=25% of planned doses of drug over 28 days due to treatment-related AEs in first cycle. | The DLT-evaluable population included as all participants who received at least 75% of their planned mobocertinib doses for their first cycle of treatment (unless interrupted by study drug-related AEs). As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Number | DLTs | Cycle 1 (Cycle length=28 days) |
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| Secondary | Phase 1 Part: Maximum Tolerated Dose (MTD) of Orally Administered Mobocertinib | The MTD was declared when at least 9 participants were evaluable in the study and 6 participants were evaluable at the current dose, and the current dose was recommended for the next cohort. | The DLT-evaluable population was defined as all participants who received at least 75% of their planned mobocertinib doses for their first cycle of treatment (unless interrupted by study drug-related AEs). As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Number | mg | Cycle 1 (Cycle length=28 days) |
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| Secondary | Phase 1 Part, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose | The pharmacokinetic (PK) population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. As planned, this outcome measure was assessed only for Phase 1 Part of the study | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Cycle 1 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
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| Secondary | Phase 1 Part, Tmax: Time of First Occurrence of Cmax for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose | The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Median | Full Range | hour | Cycle 1 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
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| Secondary | Phase 1 Part, AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose | The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. Here number analyzed 'n' signifies participants who were evaluable for specified categories. As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Cycle 1 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
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| Secondary | Phase 1 Part, Cmax, ss: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
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| Secondary | Phase 1 Part, Tmax, ss: Time of First Occurrence of Cmax for Mobocertinib Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Median | Full Range | hour | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
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| Secondary | Phase 1 Part, AUC24, ss: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
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| Secondary | Phase 1 Part, Rac (AUC 24): Extent of Accumulation Ratio Based on AUC 24 on Multiple Dosing for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses | Rac (AUC 24) was calculated as the ratio of drug concentrations observed during a dosing interval at steady state divided by drug concentrations seen during the dosing interval after a single (first) dose. Rac (AUC 24) = AUC(0-24) on Cycle 2 Day 1/ AUC(0-24) on Cycle 1 Day 1. | The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Cycle 2 Day 1: pre-dose and at 0.5 1, 2, 4, 6, 8 and 24 hours post-dose (Cycle length = 28 days) |
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| Secondary | Phase 1 Part: ORR in Participants With EGFR Mutations as Assessed by Investigator | Investigator assessed ORR using RECIST version 1.1 in participants with EGFR mutations. ORR was defined as the percentage of participants achieving CR and PR per RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. All participants with ORR had documentation of EGFR exon 20 insertion mutation. | The response-evaluable population was defined as participants who received at least 1 dose of mobocertinib, had measurable disease at baseline, and at least 1 post-baseline response assessment. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of study. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of the study drug until PD (up to 2 years and 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 1 Part: ORR in Participants With HER2 Mutations as Assessed by Investigator | Investigator assessed ORR using RECIST version 1.1 in participants with HER2 mutations. ORR was defined as the percentage of participants achieving CR and PR per RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. | The response-evaluable population was defined as participants who received at least 1 dose of mobocertinib, had measurable disease at baseline, and at least 1 post-baseline response assessment. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of study. | Posted | Number | percentage of participants | From the first dose of the study drug until PD (up to 2 years and 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: Confirmed ORR as Assessed by the Investigator | Confirmed ORR was defined as the percentage of the participants who were confirmed to have achieved CR or PR per the investigator using RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging >=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of the study drug until PD (up to 2 years and 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: Duration of Response (DOR) as Assessed by the IRC as Per RECIST V1.1 | Duration of response as assessed by the IRC was defined as the time interval from first documentation of CR/PR (whichever is first recorded) until the first date that PD is objectively documented. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD. PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest); PD (non-target lesion response): Unequivocal progression of existing non-target lesions. The SLD must also demonstrate an absolute increase of at least 5 mm. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Median | 95% Confidence Interval | months | From first documentation of CR/PR until first PD (Up to 2 years and 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: DOR as Assessed by Investigator as Per RECIST V1.1 | Duration of response as assessed by the investigator was defined as the time interval from first documentation of CR/PR (whichever is first recorded) until the first date that PD is objectively documented. CR (target lesion response):disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD. PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest); PD (non-target lesion response): Unequivocal progression of existing non-target lesions. The SLD must also demonstrate an absolute increase of at least 5 mm. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Median | 95% Confidence Interval | months | From first documentation of CR/PR until first PD (Up to 2 years and 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: Time to Response as Assessed by the IRC as Per RECIST V1.1 | Time to response as assessed by the IRC was defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for participants with confirmed CR/PR. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Median | Full Range | days | From the first dose of the study drug up to first confirmed CR or PR (Up to 2 years 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: Time to Response as Assessed by the Investigator Per RECIST V1.1 | Time to response as assessed by the investigator was defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for participants with confirmed CR/PR. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Median | Full Range | days | From the first dose of the study drug up to first confirmed CR or PR (Up to 2 years 9 months, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: Disease Control Rate (DCR) as Assessed by the IRC as Per RECIST V1.1 | DCR as assessed by IRC was defined as percentage of participants achieved CR, PR, stable disease (SD) (measurements must had met SD criteria at least once after study entry at minimum interval of 42 days) after initiation of study drug.CR(target lesion): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis.CR(non-target lesion): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level.PR(target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.SD(target lesion): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.PD(target lesion): SLD increased by at least 20% from smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm.PD (non-target lesion): unequivocal progression of existing non-target lesions. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of the study drug until PD (Up to 2 years 9 month, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: DCR as Assessed by the Investigator Per RECIST V1.1 | DCR as assessed by investigator was defined as percentage of participants achieved CR, PR, SD (measurements must had met SD criteria at least once after study entry at minimum interval of 42 days) after initiation of study drug. CR (target lesion): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. CR (non-target lesion): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.SD (target lesion): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD(target lesion): SLD increased by at least 20% from smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm.PD (non-target lesion): unequivocal progression of existing non-target lesions. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of the study drug until PD (Up to 2 years 9 month, till data cut-off of 08 November 2021) |
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| Secondary | Phase 2 Part: Progression Free Survival (PFS) as Assessed by the IRC as Per RECIST V1.1 | PFS as assessed by the IRC was defined as the time interval from the start of study treatment until to the first documentation of PD or death due to any cause (whichever comes first) according to RECIST version 1.1.PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. PD (non-target lesion response): unequivocal progression of existing non-target lesions. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Median | 95% Confidence Interval | months | From the first dose of the study drug until PD or death due to any cause (whichever comes first) (Up to 2 years and 9 months, till data cut-off of 08 November 2021 |
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| Secondary | Phase 2 Part: PFS as Assessed by the Investigator as Per RECIST V1.1 | PFS as assessed by the investigator was defined as the time interval from the start of study treatment until to the first documentation of PD or death due to any cause (whichever comes first) according to RECIST version 1.1.PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. PD (non-target lesion response): unequivocal progression of existing non-target lesions. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Median | 95% Confidence Interval | months | From the first dose of the study drug until PD or death due to any cause (whichever comes first) (Up to 2 years and 9 months, till data cut-off of 08 November 2021 |
|
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| Secondary | Phase 2 Part: Overall Survival (OS) | OS was defined as the interval from the date of the first dose of the study treatment until death due to any cause. | The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Median | 95% Confidence Interval | months | From the start of the study drug up to death due to any cause (Up to 2 years 9 months, till data cut-off of 08 November 2021) |
|
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| Secondary | Phase 2 Part: Change From Baseline in Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | EORTC QLQ-C30, version 3.0 was a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); a global health status (GHS)/quality-of-life (QoL) scale; and a six single-item scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores converted into scale scores ranging from 0 to 100. For functional and GHS/QoL scales, higher scores represent better HRQoL (positive change from Baseline=improvement), for symptom scales lower scores represent better QoL (i.e., a low level of symptomatology/problems) (negative change from Baseline=improvement), and for six-single item scale, lower scores represent better HRQoL (negative change from Baseline=improvement). | FAS included all participants who received at least one dose of mobocertinib. Here number analyzed 'n' signifies participants who were evaluable for specified categories. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 30 days after last dose (at Month 19) |
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| Secondary | Phase 2 Part: Change From Baseline in Patient-reported Symptoms (Particular Core Symptoms of Lung Cancer), Functioning, and HRQoL as Assessed by the EORTC Lung Cancer Module QLQ-LC13 | HRQOL scores was assessed with EORTC, it is a lung cancer module QLQ-LC13, version 3.0. QLQ-LC13 included 13 questions (4-point scale where 1=Not at all [best] to 4=Very much [worst]) assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain [chest, arm or shoulder, other parts]), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Subscale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. | The full analysis set (FAS) included all participants who received at least one dose of mobocertinib. Here number analyzed 'n' signifies participants who were evaluable for specified categories. As planned, this outcome measure was assessed only for Phase 2 Part of the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 30 days after last dose (at Month 19) |
|
|
TEAEs were adverse events that started after the first dose of study drug up to 30 days after the last dose of study drug or initiation of the subsequent anticancer therapies, whichever comes first (Up to 2 years and 9 months, till data cut-off of 08 November 2021)
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 | Mobocertinib 40 mg, Phase 1 Part | Mobocertinib 40 mg (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG001 | Mobocertinib 120 mg, Phase 1 Part | Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. | 1 | 4 | 3 | 4 | 4 | 4 |
| EG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. | 0 | 12 | 3 | 12 | 12 | 12 |
| EG003 | Mobocertinib 160 mg, Phase 2 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. | 2 | 33 | 11 | 33 | 33 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Gastrointestinal mucosal disorder | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | 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 | Jan 14, 2022 | Nov 6, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720862 | mobocertinib |
Not provided
Not provided
Not provided
| Greater than or equal to (>=) 50 to < 65 years |
|
| >=65 to <75 years |
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| >=75 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| IV |
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| IVA |
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| IVB |
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| Other |
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| 1 |
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| Was not involved |
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| Former Smoker |
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|
| OG001 | Mobocertinib 120 mg, Phase 1 Part | Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| OG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
|
|
| OG001 | Mobocertinib 120 mg, Phase 1 Part | Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| OG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
|
|
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Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
|
|
Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
|
|
Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC.
|
|
Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
|
|
| OG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
|
|
| OG001 | Mobocertinib 120 mg, Phase 1 Part | Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| OG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
|
|
| OG001 | Mobocertinib 120 mg, Phase 1 Part | Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
| OG002 | Mobocertinib 160 mg, Phase 1 Part | Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC. |
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