A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib (AMG 510) in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
- Conditions
- colorectaal kanker / pancreas kankercancerDeadly tumors10017990
- Registration Number
- NL-OMON53961
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
For the full list of inclusion criteria please refer to section 5.1 of the
subprotocols.
All subprotocols:
• Pathologically documented, metastatic colorectal cancer / metastatic
pancreatic cancer with KRAS p.G12C mutation identified through molecular
testing. KRAS p.G12C mutation must be identified by an approved diagnostic
device for detection of KRAS p.G12C in NSCLC or be performed in a Clinical
Laboratory Improvement Amendments (CLIA)-certified laboratory.
• Measurable disease per RECIST 1.1 criteria (Section 11.8)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2
• Life expectancy of > 3 months, in the opinion of the investigator
• Ability to take oral medications and willing to record daily adherence to
investigational product
• Corrected QT interval (QTc) <= 470 msec for women and <= 450 msec for men
(based on average of screening triplicates
• Adequate hematological laboratory assessments, as follows:
- Absolute neutrophil count (ANC) >= 1.5 x 109/L
- Platelet count >= 100 x 109/L
- Hemoglobin >= 9 g/dL
• Adequate renal laboratory assessments, as follows:
- Estimated glomerular filtration rate based on Modification of Diet in Renal
Disease (MDRD) calculation >= 60 ml/min/1.73 m2
For the full list of exclusion criteria please refer to section 5.2 of the
subprotocols.
All sub protocols
• History or presence of hematological malignancies unless curatively treated
with no evidence of disease >= 2 years
History of other malignancy within the past 2 years, with the following
exceptions:
- Malignancy treated with curative intent and with no known active disease
present for >2 years before enrollment and felt to be at low risk for
recurrence by the treating physician.
- Adequately treated non-melanoma skin cancer or lentigo maligna without
evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Adequately treated breast ductal carcinoma in situ without evidence of
disease.
- Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma
in situ.
• Myocardial infarction within 6 months of study day 1, symptomatic congestive
heart failure (New York Heart Association > class II), unstable angina, or
cardiac arrythmia requiring medication
• GI tract disease causing the inability to take oral medication, malabsorption
syndrome, requirement for IV alimentation, uncontrolled inflammatory GI disease
(eg, Crohn's disease, ulcerative colitis)
• Exclusion of hepatitis infection based on the following results and/or
criteria:
- Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic
Hepatitis B or recent acute hepatitis B)
- Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B
core antibody testing is not required for screening, however if this is done
and is positive, then hepatitis B surface antibody [antiHBs] testing is
necessary. Undetectable anti-HBs in this setting would suggest unclear and
possible infection and needs exclusion).
- Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase
chain reaction (PCR) is necessary. Detectable Hepatitis C virus RNA suggests
chronic hepatitis C
• Known positive test for HIV
• Has an active infection requiring systemic therapy
• Received radiation therapy to the lung that is > 30 Gy within 6 months of the
first dose of trial treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dose-limiting toxicities, treatment-emergent adverse events, treatment related<br /><br>adverse events, and clinically significant changes in vital signs,<br /><br>electrocardiograms (ECGs), and clinical laboratory tests<br /><br>The primary analysis for this study will occur when target enrollment is<br /><br>complete and each subject either completes at least 6 months on study or<br /><br>withdraws from the study.<br /><br>The final analysis will be conducted and reported following the end of the<br /><br>study. The end of study date is defined as the date when the last subject<br /><br>across all sites is assessed or receives an intervention for evaluation in the<br /><br>study (ie, last subject last visit), including any additional parts in the<br /><br>study (eg, long*term follow*up), as applicable. </p><br>
- Secondary Outcome Measures
Name Time Method