RecruitingEarly Phase 1

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether drug or treatment combinations chosen based on each person’s cancer may help control it. It is for adults with colorectal cancer (cancer of the colon or rectum) that has spread to other parts of the body.

To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have colorectal cancer confirmed by testing tissue or cells.
  • Have cancer with non-MSI-H/pMMR test results, which describe how cancer cells repair DNA.
  • Have a tumor that can be measured and safely biopsied (have a small tissue sample removed).
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Women who can become pregnant must use approved birth control before, during, and for a required time after treatment.
  • Men must also use approved birth control before, during, and for a required time after treatment.
  • Be willing and able to sign a consent form and have the required biopsies.

Who can't join

  • Be pregnant.
  • Have another cancer now, or within the year before consent, that could affect study safety or results.
  • Plan to have treatment meant to cure the cancer, such as surgery to remove it.
  • Have received both oxaliplatin and irinotecan for cancer that has spread. Oxaliplatin given after surgery also counts if the cancer returned within 6 months.
  • If treated for cancer that has spread, have cancer that has not worsened on the most recent treatment, based on symptoms or scans.
  • Be taking part in another study that tests a treatment or other medical intervention.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Eligibility Criteria * The participant has a histologically or cytologically confirmed diagnosis of colorectal cancer. * Confirmation of non-MSI-H/pMMR status. * Tumor that is measurable as per RECIST v1.1 and biopsy able, defined as lesion/tumor that can be biopsied without undue risk. * Age ≥ 18 years. * ECOG performance status 0-2. * Due to the potential teratogenic effect of chemotherapy, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen. * The participant is willing and able to sign the informed consent in compliance with protocol requirements, including mandatory biopsies. Exclusion Criteria * Pregnancy. * Participants with concurrent or recent (less than 1 year before consent) malignancies that have the potential to interfere with the study safety and/or endpoint assessments will be excluded. * Participants for whom there is an intent to proceed to curative therapy (i.e., resection) will be excluded. * Participants who have undergone treatment with both oxaliplatin and irinotecan in the metastatic setting will be excluded. Treatment with oxaliplatin in the adjuvant setting with relapse within 6 months will be counted as treatment in the metastatic setting for the purpose of this criterium. * For participants who have undergone treatment for metastatic disease, participants who have not progressed (clinically or radiographically) on the most recent therapy will be excluded. * Concurrent participation in any other interventional trial.

Study sites (1)

TX