GO42144
- Conditions
- Cancer
- Registration Number
- PACTR202203779032822
- Lead Sponsor
- Genentech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 10
? Signed Informed Consent Form
? Age =18 years at time of signing Informed Consent Form
? Ability to comply with the study protocol, in the investigator’s judgment
? Evaluable or measurable disease per RECIST v1.1
? Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
? Life expectancy of =12 weeks
? Adequate hematologic and organ function within 14 days prior to initiation of study
treatment, defined by the following:
? Absolute neutrophil count =1200/µL
? Hemoglobin =9 g/dL
? Platelet count =100,000/µL
? Total bilirubin =1.5 x ULN
? Serum albumin =2.5 g/dL
? AST and ALT=2.5 x ULN with the following exception:
Patients with documented liver metastases may have AST and/or
ALT =5.0 x ULN.
? For women of childbearing potential: Agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception, and agreement to refrain from
donating eggs, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate
of < 1% per year and must refrain from donating eggs during the treatment
period and after the final dose of study treatment for at least:
? 6 months for GDC-6036
? 5 months for atezolizumab (Arm B)
? 2 months for cetuximab (Arm C)
? 6 months for bevacizumab (Arm D)
? 2 weeks for erlotinib (Arm E)
? 6 months for GDC-1971 (Arm F)
? Inability or unwillingness to swallow pills
? Inability to comply with study and follow-up procedures
? Malabsorption syndrome or other condition that would interfere with enteral
absorption
? Known and untreated, or active central nervous system (CNS) metastases
(progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Patients with a history of treated CNS metastases are eligible, provided they
meet all of the following criteria:
- Measurable or evaluable disease outside the CNS
- No history of intracranial hemorrhage or spinal cord hemorrhage
- No ongoing requirement for corticosteroids as therapy for CNS
metastases, with corticosteroids discontinued for ? 2 weeks prior to
enrollment and no ongoing symptoms attributed to CNS metastases
- No stereotactic radiation within 7 days or whole-brain radiation within
14 days prior to Day 1 of Cycle 1
- No evidence of interim progression between the completion of
CNS-directed therapy and the screening radiographic study
- Note: Patients with new asymptomatic CNS metastases detected at
screening are eligible for the study after receiving radiotherapy and/or
surgery. Following treatment, these patients may be eligible without the
need to repeat the additional brain scan, if all other criteria are met.
? Leptomeningeal disease or carcinomatous meningitis
? Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures biweekly or more frequently
Indwelling pleural or abdominal catheters may be allowed, provided the patient
has adequately recovered from the procedure, is hemodynamically stable and
symptomatically improved, and after discussion with the Medical Monitor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety objective for this study is to evaluate the safety of GDC-6036 as a single agent and<br>in combination with other anti-cancer therapies on the basis of the following endpoints:<br>? Incidence and severity of adverse events, with severity determined according to National<br>Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0<br>(NCI CTCAE v5.0)<br>? Incidence and nature of dose-limiting toxicities (DLTs)<br>? Change from baseline in targeted vital signs<br>? Change from baseline in targeted clinical laboratory test results<br>? Change from baseline in targeted ECG parameters
- Secondary Outcome Measures
Name Time Method