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Platinum-containing Compound
Ipatasertib + Chemoradiation for Head and Neck Cancer
Phase 1
Recruiting
Led By Malcolm D Mattes
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow tablets at the time of enrollment
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the safety and best dose of ipatasertib in combination with chemo-radiation in patients with stage III-IVB head and neck cancer. Ipatasertib is an AKT inhibitor, which may stop the growth of tumor cells and cisplatin is a chemotherapy which works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.
Who is the study for?
Adults with advanced head and neck cancer who can swallow tablets, have no prior treatment for their current cancer, and meet certain health criteria. They must not be pregnant or breastfeeding, have serious liver disease, uncontrolled illnesses like infections or diabetes requiring insulin, nor a history of allergic reactions to similar drugs.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dose of Ipatasertib when added to standard chemo-radiation therapy in treating head and neck cancers. It compares the effects of this combination against usual treatments alone to see if it's more effective in stopping tumor growth.See study design
What are the potential side effects?
Ipatasertib may cause side effects such as high blood sugar levels, diarrhea, rash, fatigue, and nausea. Cisplatin can lead to kidney problems, hearing loss, nerve damage while radiation therapy might result in skin irritation at the treated site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My head or neck cancer is confirmed and can be measured.
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I am eligible for treatment with cisplatin and radiation at the same time.
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My throat cancer has been tested for HPV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) and recommended phase 2 dose of ipatasertib in combination with definitive chemo-radiation
Secondary outcome measures
Acute and late toxicities
Duration and completion rate of prescribed radiation and chemotherapy
Locoregional control
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion (ipatasertib, cisplatin, radiation therapy)Experimental Treatment8 Interventions
Patients receive ipatasertib PO MTD on days 2-28 or 3-28 of cycle 1 and 1-28 of subsequent cycles. Patients also receive cisplatin IV weekly on day 1 of cycle 1, weeks 1-4 and day 1 of cycle 2, weeks 1-3 for 7 doses. Patients undergo RT daily (Monday-Friday) for 35 fractions during weeks 1-7. Treatment repeats every 28 days for a total of 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT, CT, or MRI during screening, follow-up, and as clinically indicated. Patients undergo blood sample collection and tumor biopsy on trial.
Group II: Dose Escalation (ipatasertib, cisplatin, radiation therapy)Experimental Treatment7 Interventions
Patients receive ipatasertib PO QD or Monday, Wednesday, and Friday depending on dose level on days 1-28 of each cycle. Patients also receive cisplatin IV weekly on day 1 of cycle 1, weeks 1-4 and day 1 of cycle 2, weeks 1-3 for 7 doses. Patients undergo RT daily (Monday-Friday) for 35 fractions during weeks 1-7. Treatment repeats every 28 days for a total of 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT, CT, or MRI during screening, follow-up, and as clinically indicated. Patients undergo blood sample collection on trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Biopsy
2014
Completed Phase 4
~1090
Cisplatin
2013
Completed Phase 3
~1940
Computed Tomography
2017
Completed Phase 2
~2720
Ipatasertib
2011
Completed Phase 3
~2320
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,636 Total Patients Enrolled
Malcolm D MattesPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar levels when fasting should be less than or equal to 150 mg/dL, and your HbA1c level should be less than or equal to 7.5%.My cancer originates from the nasopharynx, salivary, thyroid, parathyroid glands, or skin.I can swallow pills.I do not have any uncontrolled illnesses or active infections.I have a condition that affects how my body absorbs food.I am 18 years old or older.I have a lung condition or infection.I had hepatitis C but my recent tests show no virus.I have or had inflammatory bowel disease or active bowel inflammation.I had hepatitis B in the past but it's resolved now.I have not received any treatment for my advanced head and neck cancer.My head or neck cancer has spread to distant parts of my body.I haven't taken strong CYP3A4 or P-glycoprotein affecting drugs recently.I have another cancer, but it won't affect this treatment's safety or results.I am fully active or can carry out light work.I am HIV positive, on treatment, and my viral load is undetectable.I have Type I diabetes and need insulin.You have had allergic reactions to drugs similar to ipatasertib or other drugs being used in the study.My head or neck cancer is confirmed and can be measured.Your blood and other test results need to be within certain limits.I am eligible for treatment with cisplatin and radiation at the same time.I agree to have biopsies during the treatment.I have high cholesterol or triglycerides that are not under control.My tumor is either not tested for p16 or is p16-negative, and my cancer is stage III-IVB.My throat cancer has been tested for HPV.I have a serious liver condition.My p16-positive tumor is at stage III.You are expected to live for more than 3 months.Your kidneys work well enough to clear a certain amount of waste from your body.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (ipatasertib, cisplatin, radiation therapy)
- Group 2: Dose Expansion (ipatasertib, cisplatin, radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been admitted to this clinical experiment?
"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is ongoing and began on April 12th 2022 with a most recent update taking place November 24th of the same year. With 4 sites participating in total, 36 candidates are needed to take part."
Answered by AI
What types of conditions can be effectively managed with Radiation Therapy?
"Radiation Therapy has a wide array of applications, including treatment for advanced ovarian cancer. This form of therapy is also effective in treating conditions such as refractory to standard therapies, neoplasm metastasis, and advance directives."
Answered by AI
Is there still an opportunity to join this clinical venture?
"As evidenced by the information showcased on clinicaltrials.gov, this medical research study is actively searching for volunteers to participate. The trial was first unveiled on April 12th 2022 and underwent its latest revision November 24th of that same year."
Answered by AI
Has the FDA sanctioned Radiation Therapy?
"Taking into account the limited evidence of safety and efficacy, our team at Power has rated Radiation Therapy a score 1 on their scale from 1 to 3."
Answered by AI
Could you provide details of any previous experiments involving Radiation Therapy?
"Currently, there are 775 medical studies employing Radiation Therapy. 294 of these trials have progressed to Phase 3. Shanghai is the most popular city for this type of research with 46863 locations offering it as a treatment option."
Answered by AI
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