Metastatic CancerPhase 4GENIUSNCT02000739
Genetically-informed Therapies for Patients With Metastatic Cancer
A Phase 4 study testing Genetically Informed Therapy in people with Metastatic Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Genetic mutations associated with cancer are being discovered and new treatments are being created to treat people whose cancer tumors have certain genetic mutations. Genetic sequencing of a tumor can be done, and in this study that information is sent to a company called "N-of-One." They will match each patient's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Genetically Informed Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic cancer that has progressed by RECIST criteria on at least 1 prior therapy in the metastatic setting.
- Patients must have not received anti-cancer therapy (i.e., EGFR, BRAF, AR, ER or Her2 targeted agents , chemotherapy, radiation or surgery) within the last 4 weeks, and must have recovered to Grade 2 or better from all treatment-related adverse events.
- Karnofsky performance status ≥ 60%
- Women should not be lactating or pregnant. If of childbearing age, she must have a negative pregnancy test within two weeks of entry to the study and practice effective birth control during the study.
- Patient must be mentally competent and provide written informed consent for study participation.
- Tumor tissue must be obtained through a clinically indicated biopsy or surgical procedure, performed as standard-of-care for progression of disease.
- Patient must consent to the use of blood, plasma, and tumor tissues for research purposes. Only tumor genetic information will be used to recommend therapy in this study. Tumor, blood and/ or plasma may be retrospectively analyzed for research purposes.
- Patients must be willing to consent to paying for the supply of drug if necessary. Cost estimates will be provided at the time of consent. As per the current standard of care for prescription drugs, the treating oncologist and his/her staff will be responsible for making every effort to obtain reimbursement and/or find the lowest possible cost of drug to minimize out of pocket costs.
Who cannot join
- Concomitant second invasive malignancy within five years of enrollment except for non- melanoma skin cancer.
- In patients with a prior history of invasive malignancy, less than five years in complete remission.
- Evidence of significant comorbidities such as uncontrolled diabetes, hypertension or active infection that would preclude treatment on a proposed regimen.
- Prior treatment with proposed regimen.
- Clinically significant gastrointestinal abnormalities including but not limited to malabsorption syndrome, major resection of stomach or small bowel affecting absorption of oral drugs, active peptic ulcer disease, inflammatory bowel disease, history of small bowel obstruction abscess or fistula within 28 days prior to beginning study treatment.
- Presence of uncontrolled infection.
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- Known lesion infiltrating major vessels, with risk of bleeding or perforation, as determined by radiographic review.
- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.
- Any ongoing toxicity from prior anti-cancer therapy that is Grade 3 or higher and /or progressing in severity.
- Untreated brain metastasis that have progressed within the 8-week period prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Phase II GENIUS Trial of GENetically-Informed Therapies for Patients With previoUSly Treated Refractory Metastatic Cancer
Genetic mutations associated with cancer are being discovered and new treatments are being created to treat people whose cancer tumors have certain genetic mutations. Genetic sequencing of a tumor can be done, and in this study that information is sent to a company called "N-of-One." They will match each patient's tumor's genetic profile to targeted therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of FDA-approved drugs, or use of experimental drugs in clinical research studies open at various locations in the region.
The purpose of the study is to compare the length of time it takes for a tumor to grow in people who receive the standard treatment for metastatic cancer to the length of time it takes for a tumor to grow in people who receive a drug specifically targeted for their cancer's genetic mutation.
Read more
Investigators will do a kind of genetic testing called "DNA sequencing". Everyone who takes part in this trial will have genetic testing done on their cancer tumor tissue here at Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above.
The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing.
If there is no genetic mutation that can be identified with current DNA sequencing, participants will receive the standard treatment for metastatic cancer.
If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant.
Because there are many drugs that may be used in this study, the investigator cannot advise in advance whether or not the drug a participant might receive has been approved by the U.S. Food and Drug Administration (FDA).
Read the detailed description
Treatment with a personalized targeted therapy plan based on cancer genetics will improve time to disease progression (TTP) compared to standard therapies.
By comparing A) a patient's TTP on targeted therapy vs. B) their TTP on their most recent prior therapy, investigators will minimize the variability in TTP observed across cancer subtypes, and be able to enroll patients with any type of solid tumor in a statistically unbiased manner. Based on the literature, investigators expect at least 35% of patients treated with a genetically-informed targeted therapy to exhibit a longer progression-free interval than would be expected with standard therapies. This "TTP ratio" for each patient is calculated using the formula:
TTP ratio: (TTP on targeted therapy) / (TTP on most recent non-targeted therapy)
An individual patient's benefit from genetically-informed targeted therapy is defined as a TTP ratio ≥ 1.3
- Conditions
- Metastatic Cancer
- Being tested
- Genetically Informed Therapy
- Keywords
- Breast cancer, melanoma, GI cancer, ovarian cancer, lung cancer, metastatic cancer, brain cancer, head and neck cancer
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Melanoma, Gastrointestinal Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Brain Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetically Informed TherapyGenetic
Also called Patient Specific
If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant.
| Study group | Role | What they receive |
|---|---|---|
| Genetically Informed Therapy | Other | The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing.
If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant. Receives: Genetic: Genetically Informed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
All patients considered for entry should be consented and have measurable disease as described in the Response Evaluation Criteria in Solid Tumors criteria. Within 4 weeks of cycle 1 day 1 the following are required:
- CT Chest/abdomen/pelvis with contrast and bone scan or PET scan
- Brain MRI or CT head with contrast- if indicated
Measured: up to week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary D Chamberlin, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000739
- Sponsor's protocol ID
- D13214
- Acronym
- GENIUS
- Status last verified
- Jul 2014
- First submitted
- 6 Nov 2013
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II GENIUS Trial of GENetically-Informed Therapies for Patients With previoUSly Treated Refractory Metastatic Cancer
- ClinicalTrials.gov ID
- NCT02000739
- Acronym / sponsor ID
- GENIUS / D13214
- Conditions
- Metastatic Cancer
- Keywords
- Breast cancer, melanoma, GI cancer, ovarian cancer, lung cancer, metastatic cancer, brain cancer, head and neck cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genetic mutations associated with cancer are being discovered and new treatments are being created to treat people whose cancer tumors have certain genetic mutations. Genetic sequencing of a tumor can be done, and in this study that information is sent to a company called "N-of-One." They will match each patient's tumor's genetic profile to targeted therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of FDA-approved drugs, or use of experimental drugs in clinical research studies open at various locations in the region.
The purpose of the study is to compare the length of time it takes for a tumor to grow in people who receive the standard treatment for metastatic cancer to the length of time it takes for a tumor to grow in people who receive a drug specifically targeted for their cancer's genetic mutation.
Investigators will do a kind of genetic testing called "DNA sequencing". Everyone who takes part in this trial will have genetic testing done on their cancer tumor tissue here at Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above.
The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing.
If there is no genetic mutation that can be identified with current DNA sequencing, participants will receive the standard treatment for metastatic cancer.
If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant.
Because there are many drugs that may be used in this study, the investigator cannot advise in advance whether or not the drug a participant might receive has been approved by the U.S. Food and Drug Administration (FDA).
Detailed description
Treatment with a personalized targeted therapy plan based on cancer genetics will improve time to disease progression (TTP) compared to standard therapies.
By comparing A) a patient's TTP on targeted therapy vs. B) their TTP on their most recent prior therapy, investigators will minimize the variability in TTP observed across cancer subtypes, and be able to enroll patients with any type of solid tumor in a statistically unbiased manner. Based on the literature, investigators expect at least 35% of patients treated with a genetically-informed targeted therapy to exhibit a longer progression-free interval than would be expected with standard therapies. This "TTP ratio" for each patient is calculated using the formula:
TTP ratio: (TTP on targeted therapy) / (TTP on most recent non-targeted therapy)
An individual patient's benefit from genetically-informed targeted therapy is defined as a TTP ratio ≥ 1.3
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetically Informed Therapy | Other | Genetic: Genetically Informed TherapyThe treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing. If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed metastatic cancer that has progressed by RECIST criteria on at least 1 prior therapy in the metastatic setting.
- Patients must have not received anti-cancer therapy (i.e., EGFR, BRAF, AR, ER or Her2 targeted agents , chemotherapy, radiation or surgery) within the last 4 weeks, and must have recovered to Grade 2 or better from all treatment-related adverse events.
- Karnofsky performance status ≥ 60%
- Women should not be lactating or pregnant. If of childbearing age, she must have a negative pregnancy test within two weeks of entry to the study and practice effective birth control during the study.
- Patient must be mentally competent and provide written informed consent for study participation.
Key exclusion criteria (10 listed)
- Concomitant second invasive malignancy within five years of enrollment except for non- melanoma skin cancer.
- In patients with a prior history of invasive malignancy, less than five years in complete remission.
- Evidence of significant comorbidities such as uncontrolled diabetes, hypertension or active infection that would preclude treatment on a proposed regimen.
- Prior treatment with proposed regimen.
- Clinically significant gastrointestinal abnormalities including but not limited to malabsorption syndrome, major resection of stomach or small bowel affecting absorption of oral drugs, active peptic ulcer disease, inflammatory bowel disease, history of small bowel obstruction abscess or fistula within 28 days prior to beginning study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetically Informed TherapyAlso: Patient SpecificIf there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant. | Genetic | Genetically Informed Therapy |
Primary outcome
Time to Disease Progression
Time frame: up to week 100
All patients considered for entry should be consented and have measurable disease as described in the Response Evaluation Criteria in Solid Tumors criteria. Within 4 weeks of cycle 1 day 1 the following are required: * CT Chest/abdomen/pelvis with contrast and bone scan or PET scan * Brain MRI or CT head with contrast- if indicated
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary D Chamberlin, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genetically Informed Therapy in people with Metastatic Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: up to week 100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.