Sotorasib + Panitumumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, sotorasib and panitumumab, to assess their safety and tolerability in cancer patients already benefiting from sotorasib in another study. Participants will receive either sotorasib alone or in combination with panitumumab to determine the most effective approach. This trial may suit those currently receiving sotorasib in an Amgen study and still experiencing benefits. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you must be currently receiving sotorasib treatment, either alone or with other therapies, as part of an Amgen-sponsored trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sotorasib, when used alone, is generally well-tolerated. Common side effects include diarrhea, muscle pain, nausea, tiredness, liver problems, and cough. About 37% of patients needed a dose adjustment due to side effects, and 25% had to discontinue use.
When combined with panitumumab, skin issues such as rashes and dry skin are common, affecting 94% of patients. Other frequent side effects include diarrhea, mouth sores, and fatigue. Despite these side effects, the combination of sotorasib and panitumumab is considered to have an acceptable safety profile, even for patients with extensive prior treatments.
Overall, past studies have shown that both treatments have manageable safety profiles. Most side effects can be managed by adjusting the dose or discontinuing treatment if necessary.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Sotorasib and Panitumumab for cancer treatment because it targets cancer cells in a new way. Sotorasib works by specifically inhibiting a mutated protein called KRAS G12C, which is often found in certain cancers, providing a more precise approach compared to traditional chemotherapy. When used alongside Panitumumab, an antibody that targets the epidermal growth factor receptor (EGFR) on cancer cells, the combination can potentially block multiple pathways that cancer cells use to grow. This dual-targeted approach could lead to more effective treatment outcomes and fewer side effects than standard therapies.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that sotorasib, a treatment for cancers with the KRAS G12C mutation, yields promising results. Studies report that patients live for a median of 12.5 months and experience significant tumor shrinkage. In this trial, participants in Arm A will receive sotorasib alone, while Arm B will test the combination of sotorasib with panitumumab. Evidence suggests that this combination can extend the time patients live without their cancer worsening to 5.6 months. Additionally, this combination tends to improve patients' well-being during treatment. Both treatments have demonstrated effectiveness, offering hope for better cancer control.678910
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults over 18 with solid tumors and the KRAS p.G12C mutation, who are benefiting from ongoing Sotorasib treatment in an Amgen-sponsored study. They should be able to take oral meds, have a life expectancy of more than 3 months, and not be severely limited in daily activities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sotorasib with or without panitumumab in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Panitumumab
- Sotorasib
Trial Overview
The trial tests the safety of continuing Sotorasib alone or with Panitumumab (or other anti-cancer therapies) in patients already receiving these treatments. It's for those who've seen benefits from previous Amgen trials and aims to see if these effects last.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Sotorasib will be administered once daily, orally, in combination with Panitumumab intravenous (IV) infusion every two weeks on Day 1 and Day 15 in 28-day treatment cycles. Treatment will continue for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first.
Sotorasib will be administered once daily, orally in 28-day treatment cycles for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Real-world effectiveness and tolerability of sotorasib in ...
3.2. Sotorasib effectiveness on clinical outcomes. The median (95 % CI) duration of sotorasib treatment was 4.0 (3.5–4.4) months. Median (95 % ...
Long-Term Outcomes and Molecular Correlates of Sotorasib ...
In this long-term analysis, oral once-daily sotorasib demonstrated favorable safety profile and durable efficacy across subgroups in KRAS G12C- ...
3.
roswellpark.org
roswellpark.org/newsroom/202304-2-year-follow-shows-sotorasib-significantly-prolongs-survival-patients-non-small2-Year Follow-Up Shows Sotorasib Significantly Prolongs ...
FDA-approved therapy targets G12C mutation of KRAS gene · Overall survival rate after sotorasib: 50.8% at 1 year, 32.5% at 2 years · Reduced ...
Impact of standard vs reduced dosing of sotorasib on ...
This systematic review and meta-analysis evaluates the impact of starting at 960 mg of Sotorasib versus reduced dose on efficacy and toxicity.
Sotorasib for Lung Cancers with KRAS p.G12C Mutation
The median progression-free survival was 6.8 months, and the median overall survival was 12.5 months. In addition, tumor shrinkage and disease control were ...
Safety & Adverse Reactions | LUMAKRAS® (sotorasib)
The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough in CodeBreaK 100 (N=204).
Pooled safety analysis and management of sotorasib ...
Sotorasib has a well-characterized safety profile in patients with KRAS G12C-mutated advanced NSCLC, and key risks are manageable with dose modification.
Brief Report: Real-World Efficacy and Safety of Sotorasib in ...
Toxicity leading to sotorasib interruption or dose reduction occurred in 37% of patients, whereas sotorasib discontinuation for toxicity occurred in 25%.
214665Orig1s000 - accessdata.fda.gov
sotorasib metabolism and safety data, as well as published information. This exploratory in vitro study (153409) was conducted as a follow ...
Sotorasib: uses, dosing, warnings, adverse events, ...
Sotorasib is used as a single agent for the treatment of locally advanced or metastatic KRAS G12C mutation-positive non-small cell lung cancer (NSCLC)
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