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Anti-metabolites

CB-839 + Capecitabine for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Led By David Bajor, MD

Research Sponsored by David Bajor

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 1: Recommended dose for phase II study

PHASE 2: Number of patients with response to treatment

Secondary study objectives

PHASE 1: proportion of patient who respond to treatment

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Flu like symptoms

10%

Obesity

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Pain

Dysgeusia

Nail disorder

Respiratory infection

Abdominal pain

Osteonecrosis of jaw

Spinal cord compression

Heart failure

Bronchial infection

Pleural effusion

Ascites

Urinary tract infection

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Dislocation of hip

Palmar-plantar erythrodysesthesia syndrome

Thromboembolic event

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

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

~850

Capecitabine

2013

Completed Phase 3

~4280