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Anti-metabolites

Gemcitabine Hydrochloride for Cancer

Phase 1
Waitlist Available
Led By Alex Adjei
Research Sponsored by Mayo Clinic
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
Awards & highlights

Study Summary

This trial studies the side effects and best dose of two drugs, ribociclib and gemcitabine hydrochloride, in treating patients with solid tumors.

Eligible Conditions
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Best response defined as best objective status recorded from the start of the treatment until disease progression/recurrence
Confirmed response defined to be a stringent complete response, complete response, very good partial response, or partial response
Incidence of adverse events
+1 more
Other outcome measures
CDK2/4/6, Cyclin D1 and Cyclin D3 amplification, retinoblastoma (RB) and P16 expression

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986
97%
Neutropenia
94%
Leukopenia
80%
Anemia
76%
Thrombocytopenia
47%
Gastrointestinal
43%
Constitutional
38%
Other Hemotologic
34%
Pain
17%
Infection/Fever
17%
Peripheral neurologic
17%
Pulmonary
14%
Neurologic
11%
Metabolic
10%
2nd Primary
9%
Hepatic
8%
Dermatologic
7%
Cardiovascular
6%
Allergy
6%
Hemorrhage
5%
Genitourinary/Renal
5%
Musculoskeletal
4%
Ocular/Visual
3%
Endocrine
2%
Auditory
2%
Thrombosis/Embolism
1%
Ileus
1%
Infection Documented W Grd 3/4 Neutropn.
1%
Infection Without Neutropenia
1%
Coagulation
1%
Sexual
1%
Platelets
1%
Allergic Reaction/Hypersensitivity
1%
Febrile Neutropenia-Fuo Infect Not Docum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carbo/Gemcitabine - Carbo/Taxol
Carbo/Taxol/Gemcitabine
Carbo/Taxol/Doxil
Carbo/Topotecan - Carbo/Taxol
Carbo/Taxol

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (gemcitabine hydrochloride, ribociclib)Experimental Treatment4 Interventions
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and ribociclib PO QD on days 8-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Ribociclib
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,646 Previous Clinical Trials
40,930,984 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,200 Previous Clinical Trials
3,760,852 Total Patients Enrolled
Alex AdjeiPrincipal InvestigatorMayo Clinic
14 Previous Clinical Trials
584 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
2018. "Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03237390.
~6 spots leftby Apr 2025
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