Metastatic Malignant NeoplasmPhase 2NCT02152254
Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)
A Phase 2 study testing Targeted Therapy Based on Molecular Profiling and Standard-of-Care Therapy in people with Metastatic Malignant Neoplasm and Recurrent Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- What is being tested?
- Targeted Therapy Based on Molecular Profiling and Standard-of-Care Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,362 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2014to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients with metastatic cancer
- Patients may have received unlimited lines of prior therapy
- Prior to randomization, patients with metastatic disease must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
- The patient has measurable disease
- The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- The patient has biopsy-accessible tumor; for patients who had no prior anticancer therapy and had surgical resection within a year and tumor tissue is immediately available, that tumor will be analyzed and no biopsy will be needed
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- Absolute neutrophil count >= 1,000/ul
- Platelets >= 100,000/ul (unless these abnormalities are due to bone marrow involvement)
- Total bilirubin level <= 1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's disease
- Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase levels (SGPT) =< 2.5 X ULN (unless the patient has liver metastases)
- Serum creatinine clearance >= 50 ml/min by the Cockcroft-Gault formula
- If the patient has brain metastasis, they must have been stable (treated and/or asymptomatic) and the patient must have been off steroids for at least 2 weeks
- The patient has provided signed informed consent
- Patients with a previous malignancy (other than the patients' known cancer) that were treated successfully and are disease-free for at least 3 years are allowed
- Patients with a history of basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are eligible
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; childbearing potential will be defined as women who have had menses within the past 12 months and who have not had a tubal ligation, hysterectomy, or bilateral oophorectomy; should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately
- Male subjects must agree to use effective contraception or abstinence while on study and for 90 days after last dose of study drug
Who cannot join
- Patients who are randomized to the control arm must not receive therapy based on prior molecular profiling
- The patient has received chemotherapy, surgery, or radiotherapy (for therapeutic purposes) within 3 weeks of initiating study treatment (4 weeks for bevacizumab or investigational drugs) or the patient has not recovered (grade >= 2 from side effects of the previous therapy); patients who receive palliative radiation therapy can be treated immediately after completion of radiation therapy
- The patient has cardiac conditions as follows: uncontrolled hypertension (blood pressure [BP] > 160/100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association class II or above), baseline left ventricular ejection fraction (LVEF) =< 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate > 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction [MI] within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly)
- The patient has peripheral neuropathy >= grade 2
- The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [b-HCG], if applicable) or is breastfeeding
- The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease)
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- The patient has refractory nausea and vomiting or chronic gastrointestinal diseases (e.g., inflammatory bowel disease) or has had significant bowel resection that would preclude adequate absorption (for oral therapy only)
- The patient is unable to swallow capsules and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis (for oral therapy only)
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)
This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.
Read the detailed description
- To determine whether patients treated with a matched targeted therapy selected on the basis of genomic alteration analysis of the tumor have longer progression-free survival (PFS) than those whose treatment is not selected on the basis of alteration analysis. Genomic analysis of tumor sample will be performed at the time of enrollment to identify tumor molecular alterations and to assign treatment for every individual patient.
OUTLINE: After completion of molecular profiling, patients who qualify for the trial will be offered randomization as previously. If they wish to be randomized, patients will be randomized to one of the two arms: matched targeted therapy (ARM I) or other therapy (ARM II). Patients who decline to be randomized will then be offered their choice of the two trial arms.
ARM I: Matched targeted therapy: Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration [FDA]-approved for another indication), patients can receive the FDA-approved drug.
ARM II: Other therapy: Patients receive standard of care therapy at the discretion of the treating physician.
Patients with tumor progression who achieve the primary study endpoint can cross over to the other treatment arm.
- Being tested
- Targeted Therapy Based on Molecular Profiling, Standard-of-Care Therapy
- Medical subject headings
- Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Therapy Based on Molecular ProfilingDrug
Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration [FDA]-approved for another indication), patients can receive the FDA-approved drug.
Standard-of-Care TherapyDrug
Standard-of-care treatment regimen will be left to the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Targeted Therapy | Active comparator | Personalized treatment, targeted therapy against the alteration based on molecular profiling. Receives: Drug: Targeted Therapy Based on Molecular Profiling |
| Arm B: Standard-of-Care Therapy | Experimental | Standard-of-Care treatment not selected on basis of alteration analysis. Receives: Drug: Standard-of-Care Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
Progression-free survival (PFS) of patients treated with a targeted therapy selected on the basis of mutational analysis of the tumor compared with PFS of those whose treatment is not selected based on alteration analysis.
Measured: Continuous Monitoring, expected range from 2 months to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study start13 May 2014
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tempus AI
- Responsible party
- Sponsor
- Investigators
- Apostolia M Tsimberidou, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152254
- Sponsor's protocol ID
- PA12-1161
- Other IDs
- NCI-2016-00830, PA12-1161
- Status last verified
- Aug 2026
- First submitted
- 21 May 2014
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vo HH, Fu S, Hong DS, Karp DD, Piha-Paul S, Subbiah V, Janku F, Naing A, Yap TA, Rodon J, Ajani JA, Cartwright C, Johnson A, Song IW, Beck J, Kahle M, Nogueras-Gonzalez GM, Miller V, Chao C, Vining DJ, Berry DA, Meric-Bernstam F, Tsimberidou AM. Challenges and opportunities associated with the MD Anderson IMPACT2 randomized study in precision oncology. NPJ Precis Oncol. 2022 Oct 27;6(1):78. doi: 10.1038/s41698-022-00317-0.
PubMed 36302890Naqvi MF, Vo HH, Vining D, Tsimberidou AM. Prolonged response to treatment based on cell-free DNA analysis and molecular profiling in three patients with metastatic cancer: a case series. Ther Adv Med Oncol. 2021 Mar 24;13:17588359211001538. doi: 10.1177/17588359211001538. eCollection 2021.
PubMed 33995588Aletaha D, Alasti F, Smolen JS. Disease activity states of the DAPSA, a psoriatic arthritis specific instrument, are valid against functional status and structural progression. Ann Rheum Dis. 2017 Feb;76(2):418-421. doi: 10.1136/annrheumdis-2016-209511. Epub 2016 Jul 25.
PubMed 27457512
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)
- ClinicalTrials.gov ID
- NCT02152254
- Acronym / sponsor ID
- PA12-1161
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,362 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Tempus AI
- Study start
- 13 May 2014 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Jun 2014 (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.
This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.
Detailed description
- To determine whether patients treated with a matched targeted therapy selected on the basis of genomic alteration analysis of the tumor have longer progression-free survival (PFS) than those whose treatment is not selected on the basis of alteration analysis. Genomic analysis of tumor sample will be performed at the time of enrollment to identify tumor molecular alterations and to assign treatment for every individual patient.
OUTLINE: After completion of molecular profiling, patients who qualify for the trial will be offered randomization as previously. If they wish to be randomized, patients will be randomized to one of the two arms: matched targeted therapy (ARM I) or other therapy (ARM II). Patients who decline to be randomized will then be offered their choice of the two trial arms.
ARM I: Matched targeted therapy: Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration [FDA]-approved for another indication), patients can receive the FDA-approved drug.
ARM II: Other therapy: Patients receive standard of care therapy at the discretion of the treating physician.
Patients with tumor progression who achieve the primary study endpoint can cross over to the other treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Targeted Therapy | Active comparator | Drug: Targeted Therapy Based on Molecular ProfilingPersonalized treatment, targeted therapy against the alteration based on molecular profiling. |
| Arm B: Standard-of-Care Therapy | Experimental | Drug: Standard-of-Care TherapyStandard-of-Care treatment not selected on basis of alteration analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with metastatic cancer
- Patients may have received unlimited lines of prior therapy
- Prior to randomization, patients with metastatic disease must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
- The patient has measurable disease
- The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (9 listed)
- Patients who are randomized to the control arm must not receive therapy based on prior molecular profiling
- The patient has received chemotherapy, surgery, or radiotherapy (for therapeutic purposes) within 3 weeks of initiating study treatment (4 weeks for bevacizumab or investigational drugs) or the patient has not recovered (grade >= 2 from side effects of the previous therapy); patients who receive palliative radiation therapy can be treated immediately after completion of radiation therapy
- The patient has cardiac conditions as follows: uncontrolled hypertension (blood pressure [BP] > 160/100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association class II or above), baseline left ventricular ejection fraction (LVEF) =< 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate > 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction [MI] within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly)
- The patient has peripheral neuropathy >= grade 2
- The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [b-HCG], if applicable) or is breastfeeding
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 |
|---|---|---|
| Targeted Therapy Based on Molecular ProfilingMolecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration [FDA]-approved for another indication), patients can receive the FDA-approved drug. | Drug | Arm A: Targeted Therapy |
| Standard-of-Care TherapyStandard-of-care treatment regimen will be left to the discretion of the treating physician. | Drug | Arm B: Standard-of-Care Therapy |
Primary outcome
Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
Time frame: Continuous Monitoring, expected range from 2 months to 3 years
Progression-free survival (PFS) of patients treated with a targeted therapy selected on the basis of mutational analysis of the tumor compared with PFS of those whose treatment is not selected based on alteration analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 36302890Vo HH, Fu S, Hong DS, Karp DD, Piha-Paul S, Subbiah V, Janku F, Naing A, Yap TA, Rodon J, Ajani JA, Cartwright C, Johnson A, Song IW, Beck J, Kahle M, Nogueras-Gonzalez GM, Miller V, Chao C, Vining DJ, Berry DA, Meric-Bernstam F, Tsimberidou AM. Challenges and opportunities associated with the MD Anderson IMPACT2 randomized study in precision oncology. NPJ Precis Oncol. 2022 Oct 27;6(1):78. doi: 10.1038/s41698-022-00317-0.
- Derived from this study: PubMed 33995588Naqvi MF, Vo HH, Vining D, Tsimberidou AM. Prolonged response to treatment based on cell-free DNA analysis and molecular profiling in three patients with metastatic cancer: a case series. Ther Adv Med Oncol. 2021 Mar 24;13:17588359211001538. doi: 10.1177/17588359211001538. eCollection 2021.
- Derived from this study: PubMed 27457512Aletaha D, Alasti F, Smolen JS. Disease activity states of the DAPSA, a psoriatic arthritis specific instrument, are valid against functional status and structural progression. Ann Rheum Dis. 2017 Feb;76(2):418-421. doi: 10.1136/annrheumdis-2016-209511. Epub 2016 Jul 25.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Apostolia M Tsimberidou principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Targeted Therapy Based on Molecular Profiling and Standard-of-Care Therapy in people with Metastatic Malignant Neoplasm and Recurrent Malignant Neoplasm, run by M.D. Anderson Cancer 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 17 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms (time frame: Continuous Monitoring, expected range from 2 months to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152254, which also lists 3 linked publications.
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 10 Aug 2026.