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Cyclin-Dependent Kinase Inhibitor

Dinaciclib for Advanced Melanoma

Phase 2
Waitlist Available
Led By Christopher D Lao
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1
No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease assessment was performed every 6 weeks, up to 3 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the effects of a drug on patients with stage IV melanoma. The drug may stop the growth of tumor cells.

Who is the study for?
This trial is for adults with stage IV melanoma who've had no more than one prior systemic treatment and have recovered from its side effects. They must not be pregnant or nursing, use effective contraception, and can't have brain metastases or ocular melanoma. Participants should not consume grapefruit, take certain other drugs, or have another cancer unless in remission for 5 years.
What is being tested?
The trial tests Dinaciclib's effectiveness and side effects on stage IV melanoma patients. Dinaciclib is thought to halt tumor growth by inhibiting enzymes necessary for cell proliferation. Patients' conditions are closely monitored to assess the drug's impact.
What are the potential side effects?
While specific side effects of Dinaciclib aren't listed here, it may include symptoms common to cancer treatments such as fatigue, nausea, decreased blood counts leading to increased infection risk, liver function changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had only one treatment for stage IV melanoma and any side effects are minimal.
Select...
I am not receiving, nor do I plan to receive, any other cancer treatments outside this study.
Select...
I am not taking any drugs that strongly affect liver enzymes.
Select...
I do not have eye melanoma.
Select...
My melanoma diagnosis was confirmed with a biopsy.
Select...
It has been over 28 days since my last systemic therapy.
Select...
I can carry out all my usual activities without help.
Select...
I have never been treated with drugs that target cell growth.
Select...
My melanoma is stage IV and started in the skin or mucous membranes.
Select...
My bilirubin levels are within normal limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease assessment was performed every 6 weeks, up to 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease assessment was performed every 6 weeks, up to 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST

Side effects data

From 2016 Phase 1 & 2 trial • 36 Patients • NCT01515176
100%
Neutrophil Count Decreased
100%
Platelet Count Decreased
100%
Hyperglycemia
75%
Anemia
75%
Pain
75%
Hypoalbuminemia
75%
Hypocalcemia
50%
Alanine Aminotransferase Increased
50%
Vomiting
50%
Fatigue
50%
Lymphocyte Count Decreased
50%
Lymphocyte Count Increased
50%
White Blood Cell Decreased
50%
Hypokalemia
50%
Hypomagnesemia
50%
Paresthesia
50%
Peripheral sensory neuropathy
50%
Aspartate Aminotransferase Increased
50%
Cough
25%
Pain in Extremity
25%
Nasal congestion
25%
Myalgia
25%
Headache
25%
Hypoxia
25%
General Disorders and Administration site Conditions-other
25%
Blood Bilirubin Decreased
25%
Ankle Fracture
25%
Hypermagnesemia
25%
LEUKOCYTOSIS
25%
PLEURAL INFECTION
25%
LYMPHOCYTE COUNT DECREASED
25%
Abdominal pain
25%
Constipation
25%
Diarrhea
25%
Chills
25%
Fever
25%
Fracture
25%
Hyponatremia
25%
Hypophosphatemia
25%
Proteinuria
25%
Hyperhidrosis
25%
Nausea
25%
Bruising
25%
Musculoskeletal and connective tissue disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Level I: Treatment (Ofatumumab, Dinaciclib)
Dose Level II: Treatment (Ofatumumab, Dinaciclib)

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: Arm IExperimental Treatment1 Intervention
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats 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
Dinaciclib
2012
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,098 Total Patients Enrolled
5 Trials studying Cutaneous Melanoma
146 Patients Enrolled for Cutaneous Melanoma
Christopher D LaoPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Dinaciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00937937 — Phase 2
Cutaneous Melanoma Research Study Groups: Arm I
Cutaneous Melanoma Clinical Trial 2023: Dinaciclib Highlights & Side Effects. Trial Name: NCT00937937 — Phase 2
Dinaciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00937937 — Phase 2
~4 spots leftby Dec 2025
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