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Tests treatment safety and results for Metastatic Colorectal Cancer
Official title A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
ClinicalTrials.gov ID: NCT04929223
What this study is testing
What is Inavolisib?
Inavolisib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed cohort-specific Informed Consent Form
- Age \>= 18 years at time of signing Informed Consent Form
- Biomarker eligibility as determined by:
- A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
- A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently...
You likely can't join if
- Current participation or enrollment in another treatment clinical trial. Participants who are participating in the follow-up period of an treatment...
- Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Pregnant or breastfeeding, or intending to become pregnant during the study
- History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the...
- Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact...
See the full eligibility criteria
- Signed cohort-specific Informed Consent Form
- Age \>= 18 years at time of signing Informed Consent Form
- Biomarker eligibility as determined by:
- A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
- A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of...
- Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR
- Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 1
- Life expectancy \>= 3 months, as determined by the investigator
- Histologically confirmed adenocarcinoma originating from the colon or rectum
- Metastatic disease
- Prior therapies for metastatic disease
- Ability to comply with the study protocol, in the investigators judgment
- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
- Current participation or enrollment in another treatment clinical trial. Participants who are participating in the follow-up period of an treatment clinical trial are eligible for the study.
- Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Pregnant or breastfeeding, or intending to become pregnant during the study
- History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds...
- Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
- Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or how well it works of study treatment
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic hypercalcemia
- Clinically significant and active liver disease
- Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count...
- Symptomatic, untreated, or actively progressing CNS metastases
- History of leptomeningeal disease or carcinomatous meningitis
- History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the...
- Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Duarte, California, United States
- Encinitas, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Lone Tree, Colorado, United States
- New Haven, Connecticut, United States
- Norwich, Connecticut, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Arlington Heights, Illinois, United States
- Baton Rouge, Louisiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- New Hyde Park, New York, United States
- New York, New York, United States
+ 51 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Duarte, California, United States; Encinitas, California, United States; Los Angeles, California, United States; Newport Beach, California, United States and 65 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.