CB-839 for Rectal Carcinoma

Waitlist Available · 18+ · All Sexes · Cleveland, OH

CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer

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About the trial for Rectal Carcinoma

Eligible Conditions
Rectal Carcinoma · Malignant Neoplasm of Colon · Tumors, Solid · Colorectal Neoplasms · Colorectal Carcinoma (CRC)

Treatment Groups

This trial involves 2 different treatments. CB-839 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved
FDA approved


This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Phase I
Patients must have an advanced solid tumors for whom there are no remaining treatment options or colorectal patients who have progressed on front-line fluoropyrimidine containing therapy. Patients with colorectal cancer must have progressed on at least one line of fluoropyrimidine containing therapy. Receipt of either oxaliplatin or irinotecan in combination with a fluoropyrimidine is required in the front line setting for all colorectal cancer patients unless either of these agents are otherwise contraindicated in the opinion of the treating physician. Prior regorafenib or TAS-102 therapy is not required.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Hemoglobin ≥ 9.0 g/dl
Leukocytes ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,500/mcL
Platelet count ≥ 100,000/mcL
Serum creatinine ≤ 1.5 X institutional upper limit of normal
Total bilirubin ≤ 1.5mg/dL
Aspartate Aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.5 X institutional upper limit of normal
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Odds of Eligibility
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 18 months after beginning treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 18 months after beginning treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CB-839 will improve 2 primary outcomes and 1 secondary outcome in patients with Rectal Carcinoma. Measurement will happen over the course of At least 21 days of treatment.

PHASE 1: proportion of patient who respond to treatment
Disease control rate will be determined using RECIST criteria. RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
PHASE 1: Recommended dose for phase II study
The Phase I study has been designed to define the recommended phase II dose of CB-839 and capecitabine. A traditional 3+3 dose escalation design will be adopted. Nine to twenty-four patients are expected to be enrolled, depending on the number of dose escalations and assuming that a total of 6 patients will be treated at the final recommended phase II dose level. Patients who complete the first 21 day treatment cycle of CB-839 and capecitabine chemotherapy will be included in the analysis.
PHASE 2: Number of patients with response to treatment
In the phase II component of this study, the primary endpoint is response rate. Disease control rate will be determined using RECIST criteria. RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is rectal carcinoma?

The rectum is the most common site for colorectal carcinoma in the United States. Most people found to have [colo[rectal cancer](]( in the rectum are diagnosed at a relatively early stage. The most critical period leading to the development of cancer in this region is before age 40. A significant proportion of rectal carcinomas are detected incidentally at screening examinations for other chronic diseases or as a result of synchronous (in harmony) disease. Recent findings highlights the importance of screening for rectal cancer and the need to be aware of the epidemiology of the disease.

Anonymous Patient Answer

How many people get rectal carcinoma a year in the United States?

Almost [100,000 people] get rectal and colon carcinoma a year in the United States. About 90% of all rectal cancers occur in the right side. Most [90% or 99%] occur at or below the umbilicus. Rectal cancer has the [highest incidence] rate in all males.

Anonymous Patient Answer

What are common treatments for rectal carcinoma?

A variety of modalities are often used in the treatment of rectal cancer, including surgery, radiation, chemotherapy, and immunotherapy. However, the only certain treatment for rectal cancer that can reverse the initial problem is surgical resection. Even for those with a locally advanced rectal adenocarcinoma with no evidence of distant metastases, a surgical operation remains a first line treatment for local excision because of the risk of local recurrence.

Anonymous Patient Answer

Can rectal carcinoma be cured?

Despite radical surgery and an intensive adjuvant treatment approach, 20% of patients with cT3N0-3M0 stage II and III disease die of local recurrence or distant metastases.

Anonymous Patient Answer

What causes rectal carcinoma?

The colonic carcinoma was preceded by non-malignant colorectal lesions in about 15% cases (predominantly adenoma, or Tumor Microbiota Hypomineralization Syndrome-related), whereas the rectal carcinoma showed no pre-malignant lesion on a colonoscopic examination.

Anonymous Patient Answer

What are the signs of rectal carcinoma?

Rectal carcinoma (cancerous growth of the rectum) is usually diagnosed using a patient's history and physical examination. Other testing may also be ordered. Rectal bleeding is the most common symptom of rectal carcinoma. Other symptoms of rectal cancer include changes in bowel habits and a change in the shape or size of the bowel. When it is found by the person or family physician, the cancer may be spread.

Anonymous Patient Answer

What is the average age someone gets rectal carcinoma?

The age is lower than reported as it appears that women are dying from this cancer sooner than the average. There is a need for further consideration of gender specific cancers and how they may die earlier than would be expected, as they suffer from less effective cancer treatments as a result. Cancer 2015. © 2015 American Cancer Society.

Anonymous Patient Answer

What are the latest developments in cb-839 for therapeutic use?

Recently a new formulation of the CB-839 was developed to increase its activity against human squamous cell carcinoma in vitro. It is therefore hoped that a new clinical trial will be carried out with CB-839 using this formulation.

Anonymous Patient Answer

Have there been any new discoveries for treating rectal carcinoma?

The current practice for the treatment of rectal cancer in adults is still limited. There is an absence of data regarding the long-term outcomes of curative treatment.

Anonymous Patient Answer

What is the latest research for rectal carcinoma?

Recent studies have shown that patients with early stage rectal carcinoma can expect excellent 5-year survival with optimal local excision when treated by a team trained in rectal cancer surgery with adequate training in the operative laparoscopy technique. Patients with advanced rectal cancer can expect a 20-30% cure rate for those undergoing neoadjuvant therapy followed by radical operation involving a laparoscopic approach that is routinely performed by an experienced colorectal surgeon. Current adjuvant therapy options for early stage rectal carcinoma are neoadjuvant and surgical, typically followed by curative surgery and adjuvant chemotherapy.

Anonymous Patient Answer

Have there been other clinical trials involving cb-839?

There are no other known clinical trials that specifically test the ability of CB-839 to treat colon cancer. The most relevant trials on which we relied to design our trials are listed in the 'Related articles' section.

Anonymous Patient Answer

Does rectal carcinoma run in families?

Although patients with rectal carcinoma tend to have familial features in relatives, the familial risk is not related to a common genetic lesion. To determine whether an individual patient's cancer is associated with an inherited or environmental condition, one must first rule out known risk factors and assess the other family members who might have disease. Although an increased incidence of rectal carcinoma has been described in the literature in several family types, the precise mechanism is not known. A retrospective review of the medical records of 21 kindreds with rectal carcinoma showed that only 8 of the 21 patients (37.1%) had any evidence of disease in their relatives.

Anonymous Patient Answer
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