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Gene-Targeted cancer therapy put to the test in major trial

NCT ID NCT02152254

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests whether choosing cancer treatment based on the genetic makeup of a patient's tumor works better than standard therapy. Over 1,300 people with metastatic cancer are randomly assigned to receive either a targeted drug matched to their tumor's mutations or standard care. The goal is to see if personalized treatment can delay cancer progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
targeted therapy based on molecular profiling
What this could lead to
If successful, this could show that personalizing cancer treatment based on a tumor's genetic changes helps patients live longer without their cancer growing.
What could go wrong
This is a phase 2 trial, so results are still early. It may not prove that genetic profiling improves survival, and some targeted therapies may have side effects or not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 1,362 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2014

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm Neoplasm Metastasis Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.