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Anti-metabolites

Capecitabine for Breast and GI Cancers (X7-7 Trial)

Phase 2

Waitlist Available

Led By Qamar Khan, MD

Research Sponsored by Qamar Khan

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 from day 1 of treatment, throughout treatment, up to 2 years from day 1 of treatment

Awards & highlights

X7-7 Trial Summary

This trial is testing whether a higher or lower dose of a certain chemotherapy drug is more effective and has fewer side effects.

Eligible Conditions

Gastrointestinal Cancer
Breast Cancer

X7-7 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 of treatment, throughout treatment, up to 2 years from day 1 of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 of treatment, throughout treatment, up to 2 years from day 1 of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 of treatment, throughout treatment, up to 2 years from day 1 of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Twelve-week Progression Free Survival (cohort 1 only)

Secondary outcome measures

Grade 3 or higher toxicity (cohorts 1 and 2)

Other outcome measures

Objective response rate (cohorts 1 and 2)

Side effects data

From 2020 Phase 2 & 3 trial • 151 Patients • NCT03093870

63%

Nausea

58%

Fatigue

54%

Diarrhoea

50%

Decreased Appetite

46%

Vomiting

42%

Pyrexia

42%

Hypokalaemia

38%

Abdominal Pain

33%

Constipation

33%

Blood Bilirubin Increased

29%

Abdominal Distension

29%

Hyponatraemia

29%

Dizziness

29%

Oedema Peripheral

29%

Back Pain

25%

Hypotension

25%

Stomatitis

25%

Palmar-plantar Erythrodysaethesia Syndrome

25%

Dehydration

25%

Anaemia

21%

Aspartate Aminotransferase Increased

21%

Dyspnoea

21%

Chills

21%

Dyspepsia

21%

Asthenia

21%

Proteinuria

17%

Platelet Count Decreased

17%

Alanine Aminotransferase Increased

17%

Rash

17%

Ascites

13%

Hyperbilirubinaemia

13%

Cough

13%

Abdominal Pain Upper

13%

Blood Creatinine Increased

13%

Hypomagnesaemia

13%

Dry mouth

13%

Dyspnoea exertional

13%

Weight Decreased

13%

Hypoalbuminaemia

13%

Muscular weakness

13%

Urinary tract infection

Depression

Gastrooesophageal Reflux Disease

Gamma-glutamyltransferase increased

International normalised ratio increased

Paraesthesia

Influenza like illness

Dysphonia

Malaise

Hypoaesthesia

Faeces discolored

Hypoglycemia

Acute Kidney Injury

Enterocolitis

Hematemesis

Hyperkalaemia

Hypocalcaemia

Blood alkaline phosphatase increased

Epistaxis

Bile duct obstruction

Oral pain

Neutrophil Count Decreased

Myalgia

Insomnia

Early satiety

Rhinitis allergic

Bursitis

Musculoskeletal pain

Anxiety

Dysgeusia

Acute kidney injury

Cholangitis

Cardiac arrest

Rash generalized

Respiratory Failure

Septic shock

Small intestinal obstruction

Spinal cord compression

Toxic leukoencephalopathy

Peripheral Sensory Neuropathy

Haematemesis

Hypercalcaemia

Hyponatremia

Hypoxic-ischaemic encephalopathy

Ischaemic stroke

Lung Infection

Metabolic acidosis

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Placebo and Capecitabine - Part 1

Varlitinib and Capecitabine - Safety Lead-In

Varlitinib and Capecitabine - Part 1

X7-7 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group AExperimental Treatment1 Intervention

capecitabine, 1500 mg, twice a day for 7 days on then 7 days off

Group II: Group BActive Control1 Intervention

capecitabine, 1250 mg/m2 OR 1000 mg/m2, twice a day for 14 days on then 7 days off

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~3420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Qamar KhanLead Sponsor

3 Previous Clinical Trials

381 Total Patients Enrolled

Qamar Khan, MDPrincipal InvestigatorUniversity of Kansas Cancer Center - CRC

6 Previous Clinical Trials

818 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02595320 — Phase 2

Gastrointestinal Cancer Research Study Groups: Group A, Group B

Gastrointestinal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT02595320 — Phase 2

Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02595320 — Phase 2

Frequently Asked Questions

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

Has the Food and Drug Administration sanctioned Capecitabine for patient use?

"Our assessment was that capecitabine's safety rating is a 2, as it has undergone Phase 2 trials which provide confirmation of its security but not necessarily effectiveness."

Answered by AI

In what situations is Capecitabine usually employed as a therapeutic?

"Capecitabine is a viable therapeutic option for carcinomas and other neoplasms, such as pancreatic endocrine cancer, colorectal cancer, and refractory ovarian malignancies."

Answered by AI

Are there any prior studies which have featured Capecitabine as a factor?

"Presently, 334 clinical trials involving Capecitabine are in progress with 126 at Phase 3. Woolloongabba, Queensland has the most studies dedicated to this drug; however, 12828 centres across the world have initiated research on it."

Answered by AI

How many participants are being monitored in this research?

"This clinical trial is no longer open for recruitment. It was first posted on October 5th 2015 and last updated December 4th 2021. If alternative studies interest you, there are currently 2731 trials enrolling patients with breast cancer and 334 involving Capecitabine that still have positions available."

Answered by AI

Where are the primary sites for this research endeavor?

"This clinical trial is taking place at 15 separate locations, including Topeka, Kansas City and Hays. To reduce travel-related costs for participants, individuals should select the nearest site to them."

Answered by AI

Is this research initiative recruiting participants?

"Insights from clinicaltrials.gov confirm that this research project, which was initially launched on October 5th 2015, is no longer taking partakers. However, there are over 3000 other trials actively recruiting participants currently."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Chemoradiotherapy with Capecitabine Versus Fluorouracil for Locally Advanced Rectal Cancer: A Randomised, Multicentre, Non-inferiority, Phase 3 Trial

Hofheinz, Ralf-Dieter, Frederik Wenz, Stefan Post, Axel Matzdorff, Stephan Laechelt, Jörg T Hartmann, Lothar Müller, et al.. 2012. “Chemoradiotherapy with Capecitabine Versus Fluorouracil for Locally Advanced Rectal Cancer: A Randomised, Multicentre, Non-inferiority, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(12)70116-x.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

The OncologistJournal

Conceptual and Practical Implications of Breast Tissue Geometry: Toward a More Effective, Less Toxic Therapy

Norton, Larry. 2005. “Conceptual and Practical Implications of Breast Tissue Geometry: Toward a More Effective, Less Toxic Therapy”. The Oncologist. Oxford University Press (OUP). doi:10.1634/theoncologist.10-6-370.

British Journal of CancerJournal