A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC)
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| ClinicalTrials.gov Identifier: NCT04632992 |
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Recruitment Status :
Recruiting
First Posted : November 17, 2020
Last Update Posted : January 20, 2021
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Brief Summary:
This is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Unresectable or Metastatic Solid Malignancy | Drug: Entrectinib Drug: GDC-0077 Drug: Alectinib Drug: Ipatasertib Drug: Atezolizumab Drug: Trastuzumab Emtansine Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Drug: Tucatinib Drug: Investigator's Choice of Chemotherapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response |
| Actual Study Start Date : | January 13, 2021 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
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Experimental: Arm A: Entrectinib
Participants in this treatment arm must have a positive biomarker result for ROS1 gene fusion.
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Drug: Entrectinib
Entrectinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 600 milligrams (mg) per day once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
Other Names:
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Experimental: Arm B: GDC-0077
Participants in this treatment arm must have a positive biomarker result for PI3K activating mutations (PIK3CA).
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Drug: GDC-0077
GDC-0077 will be self-administered by participants orally at home (except on clinic days) at the same time each day, on a starting dose of 9 mg/day QD until disease progression, intolerable toxicity, or consent withdrawal.
Other Names:
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Experimental: Arm C: Alectinib
Participants in this treatment arm must have a positive biomarker result for ALK rearrangement.
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Drug: Alectinib
Alectinib will be self-administered by participants orally at home (except on clinic days), at the same times each day, on a starting dose of 600 mg twice a day (BID) until disease progression, intolerable toxicity, or consent withdrawal.
Other Names:
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Experimental: Arm D: Ipatasertib
Participants in this treatment arm must have a positive biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.
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Drug: Ipatasertib
Ipatasertib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg QD until disease progression, intolerable toxicity, or consent withdrawal.
Other Names:
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Experimental: Arm E: Atezolizumab + Investigator's Choice of Chemotherapy
Participants in this treatment arm must have a positive biomarker result for either tumor mutational burden (TMB) high or microsatellite instability (MSI) high/deficient mismatch repair (dMMR).
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Drug: Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).
Other Names:
Drug: Investigator's Choice of Chemotherapy Chemotherapy will consist of docetaxel, paclitaxel, or capecitabine, as determined by the investigator, and will be administered per the respective package insert and institutional guidelines. |
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Experimental: Arm F: Trastuzumab Emtansine + Atezolizumab
Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
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Drug: Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).
Other Names:
Drug: Trastuzumab Emtansine Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Other Names:
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Experimental: Arm G: PH FDC SC
Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
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Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab once every 3 weeks.
Other Names:
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Experimental: Arm H: PH FDC SC + Investigator's Choice of Chemotherapy
Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
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Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab once every 3 weeks.
Other Names:
Drug: Investigator's Choice of Chemotherapy Chemotherapy will consist of docetaxel, paclitaxel, or capecitabine, as determined by the investigator, and will be administered per the respective package insert and institutional guidelines. |
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Experimental: Arm I: Trastuzumab Emtansine + Tucatinib
Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
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Drug: Trastuzumab Emtansine
Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Other Names:
Drug: Tucatinib Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
Other Name: Tukysa™ |
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Experimental: Arm J: Trastuzumab Emtansine + Atezolizumab
Participants in this treatment arm must have a positive biomarker results for ERBB2 mutation or amplification and TMB high or MSI high/dMMR.
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Drug: Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).
Other Names:
Drug: Trastuzumab Emtansine Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Other Names:
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Primary Outcome Measures :
- Percentage of Participants with Confirmed Overall Response, as Assessed by the Investigator According to RECIST v1.1 or According to RANO Criteria for Primary CNS Tumors [ Time Frame: Up to 4 years ]RANO = Response Assessment in Neuro-Oncology; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1
Secondary Outcome Measures :
- Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
- Duration of Response, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
- Overall Survival [ Time Frame: Up to 4 years ]
- Progression-Free Survival Rate at Every 3 Months, Defined as the Percentage of Participants who are Progression-Free as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: At every 3 months until study completion (up to 4 years) ]
- Overall Survival Rate at Every 3 Months, Defined as the Percentage of Participants who are Alive [ Time Frame: At every 3 months until study completion (up to 4 years) ]
- Percentage of Participants with Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
- Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) [ Time Frame: From Baseline until 28 days after the final dose of study drug (up to 4 years) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory and availability of a full report of the testing results. This may be from a tissue or blood sample.
- Evaluable or measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Life expectancy ≥8 weeks
- Adequate hematologic and end-organ function, as defined in the protocol, obtained within 14 days prior to initiation of study treatment
- Agrees to take measures to prevent pregnancy in the patient or partner
- In addition to the general inclusion criteria above, in order to be enrolled in a treatment arm of the study, patients must meet all of the treatment-specific inclusion criteria for the respective arm (as detailed in the protocol)
Exclusion Criteria:
- Current participation or enrollment in another therapeutic clinical trial
- Symptomatic or actively progressing CNS metastases (asymptomatic patients with treated or untreated CNS metastases may be eligible, provided all protocol-defined criteria are met)
- History of leptomeningeal disease, unless noted otherwise for a specific treatment arm of the study
- Whole brain radiotherapy within 14 days prior to start of study treatment
- Stereotactic radiosurgery within 7 days prior to start of study treatment
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact patient safety
- Receipt of any anticancer drug/biologic or investigational treatment 21 days prior to Cycle 1, Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1, Day 1
- Known HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV) infection with status outside of study-allowed criteria
- History of or concurrent serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
- History of malignancy other than disease under study within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
- Major surgical procedure, other than for diagnosis, or significant traumatic injury within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
- Pregnant or breastfeeding, or intending to become pregnant during the study
- In addition to the general exclusion criteria above, there are treatment-specific exclusion criteria for each respective treatment arm (as detailed in the protocol)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632992
Contacts
| Contact: Reference Study ID Number: ML42439 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
Locations
Show 24 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Genentech, Inc. |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT04632992 |
| Other Study ID Numbers: |
ML42439 |
| First Posted: | November 17, 2020 Key Record Dates |
| Last Update Posted: | January 20, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neoplasms Trastuzumab Pertuzumab Ado-trastuzumab emtansine Atezolizumab Maytansine Entrectinib Antineoplastic Agents, Immunological |
Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors |