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Anti-metabolites

CB-839 + Capecitabine for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by David Bajor, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months after beginning treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to see if it is effective and safe.

Eligible Conditions

Colorectal Cancer
Colon Cancer
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months after beginning treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months after beginning treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months after beginning treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PHASE I: Recommended Dose for Phase II Study

PHASE II: Progression-free Survival (PFS)

Secondary study objectives

PHASE I: Dose-limiting Toxicities

PHASE I: Proportion of Patient Who Respond to Treatment

PHASE II: Number of Patients With Response to Treatment

+1 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

73%

Palmar-plantar erythrodysesthesia syndrome

58%

Fatigue

56%

Diarrhea

38%

Hypertension

38%

Nausea

30%

Mucositis

29%

Vomiting

26%

Weight loss

26%

Weight gain

24%

Anorexia

20%

Nail disorder

17%

Back pain

16%

Hypothermia

15%

Constipation

15%

Abdominal pain

14%

Neutrophil count decreased

13%

Dizziness

13%

Upper respiratory infection

13%

Headache

11%

Dyspepsia

10%

Pain in extremity

10%

Fever

10%

Obesity

10%

Dysgeusia

Arthralgia

Bone pain

Anemia

Cough

Pruritus

Flu like symptoms

Pain

Alopecia

Thromboembolic event

Bone fracture

Gastrointestinal infection

Spinal cord compression

Febrile neutropenia

Respiratory infection

Hot flashes

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Cohort 2: Palbociclib Plus Fulvestrant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CB-839 + capecitabineExperimental Treatment2 Interventions

Patients will receive CB-839 orally twice daily for 21 days (continuous administration) and capecitabine orally twice daily for 14/21 days. In the phase I portion of the study, patients will receive escalating doses of CB-839 and capecitabine and will have day 15 blood samples drawn and archived for as needed assessment of CB-839 pharmacokinetics. In the phase II portion of the study, patients will receiving 800mg CB-839 and 1000mg/m\^2 capecitabine as were determined to be safe doses during the phase I portion of the study. They will also undergo pre-treatment and post-treatment blood samples and tissue biopsies for evaluation of pharmacodynamic biomarkers.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CB-839

2017

Completed Phase 2

~900

Capecitabine

2013

Completed Phase 3

~4280