IMPACT 2: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02152254
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : January 25, 2018
Foundation Medicine
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

You are being asked to take part in this study because you have metastatic cancer (cancer that has spread to other parts of the body).

Cancer can be caused by abnormalities in genetic material (such as gene mutations). These genetic differences can be found by studying the tumor (molecular profiling). Information from molecular profiling can be used to choose treatment that may target the tumor. This is known as personalized medicine. Early studies have shown that molecular profiling has led to patients being treated with more specialized therapy than they would normally receive. At this time is it unknown whether molecular profiling and selection of treatment has different results than standard-of-care treatment.

The goal of this research study is to compare the effects of treatment based on molecular profiling to those of the standard-of-care.

This is an investigational study.

Up to 1,362 participants will take part in this study. All will be enrolled at MD Anderson and its regional care centers.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: Targeted Therapy Based on Molecular Profiling Drug: Standard-of-Care Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT 2)
Actual Study Start Date : May 13, 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Active Comparator: Arm A: Targeted Therapy
Personalized treatment, targeted therapy against the alteration based on molecular profiling.
Drug: Targeted Therapy Based on Molecular Profiling
Patients randomized to receive targeted therapy will participate in clinical trials, and will be treated at the expansion phase of Phase I clinical trials or in Phase II clinical trials. If a clinical trial is not available and a commercially available targeted therapy exists (FDA-approved for another indication), patients may receive the FDA-approved drug.

Experimental: Arm B: Standard-of-Care Therapy
Standard-of-Care treatment not selected on basis of alteration analysis.
Drug: Standard-of-Care Therapy
Standard-of-care treatment regimen will be left to the discretion of the treating physician.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with metastatic cancer.
  2. Patients may have received unlimited lines of prior therapy.
  3. 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.
  4. The patient has measurable disease.
  5. The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  6. 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.
  7. The patient has normal organ and marrow function, defined as absolute neutrophil count>/= 1,000/µl; platelets >/=100,000/µl (unless these abnormalities are due to bone marrow involvement).
  8. The patient has adequate hepatic function as defined by a total bilirubin level</=1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's disease, and alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase levels (SGPT) </= 2.5 X ULN (unless the patient has liver metastases).
  9. The patient has serum creatinine clearance >/= 50 ml/min by the Cockcroft-Gault formula.
  10. 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.
  11. The patient is >/=18 years of age.
  12. The patient has provided signed informed consent.
  13. 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.
  14. Patients with a history of basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are eligible.
  15. 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.
  16. 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:

  1. Patients who are randomized to the control arm must not receive therapy based on prior molecular profiling.
  2. 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.
  3. The patient has cardiac conditions as follows: uncontrolled hypertension (BP > 160/100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association Class II or above), prior or current cardiomyopathy, atrial fibrillation with heart rate >100 bpm, unstable ischaemic heart disease (MI within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly).
  4. The patient has peripheral neuropathy >/= grade 2.
  5. The patient is pregnant (confirmed by serum b-HCG, if applicable) or is breastfeeding.
  6. 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).
  7. 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).
  8. 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).
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02152254

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Foundation Medicine
Principal Investigator: Apostolia M. Tsimberidou, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02152254     History of Changes
Other Study ID Numbers: PA12-1161
NCI-2016-00830 ( Other Identifier: NCI CTRP Registration )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Metastatic Cancer
Molecular Profiling
Genomic alteration analysis of the tumor
Advanced Cancer Therapy
Gene mutations
Tumor biopsy
Personalized medicine

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes