Trastuzumab
DrugTrastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Herceptin
NCT Number: NCT02091141
This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Western Regional Medical Center at Cancer Treatment Centers of America, Goodyear, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
General Inclusion Criteria:
Study-Drug Specific Inclusion Criteria:
Trastuzumab plus Pertuzumab
a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
Erlotinib
Vemurafenib plus Cobimetinib
Vismodegib
a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
Alectinib
Atezolizumab
General Exclusion Criteria:
Study-Drug Specific Exclusion Criteria:
Trastuzumab plus Pertuzumab
Erlotinib
Vemurafenib plus Cobimetinib
Vismodegib
Alectinib
Atezolizumab
Trastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Herceptin
Pertuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Perjeta
Erlotinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Tarceva
Vemurafenib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Zelboraf
Cobimetinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Cotellic
Vismodegib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Erivedge
Alectinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Alecensa
Atezolizumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Other names: Tecentriq
Time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms.
Time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months)
The Objective Response Rate (ORR) is defined as the proportion of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or stable disease maintained more than 4 months (SD>4 months). Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
Time frame: From the date of first study treatment until disease progression as assessed by the investigator, or death from any cause, whichever occurs first (72.1 months)
PFS is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
Time frame: 87.5 months
Overall Survival (OS, months) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.
Time frame: From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (70.8 months)
Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.
Time frame: From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years)
Incidence, nature, and severity of Adverse Events (AE), per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) for participants enrolled prior to Version 6 of the protocol. The NCI CTCAE (v5.0) grading scale was used for assessing AE severity for participants enrolled under Version 6 of the protocol and subsequent versions.
Genentech, Inc.
Industry
My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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