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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ disease assessment was performed every 6 weeks, up to 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease assessment was performed every 6 weeks, up to 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
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 • NCT01515176100%
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%
Hypoxia
25%
Nasal congestion
25%
Myalgia
25%
Pain in Extremity
25%
Headache
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)
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
13,654 Previous Clinical Trials
40,933,081 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Christopher D LaoPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 28 days since my last chemotherapy.I've had only one treatment for stage IV melanoma and any side effects are minimal.I had surgery for my cancer and any side effects are mild.It has been over 28 days since my last surgery.I am not receiving, nor do I plan to receive, any other cancer treatments outside this study.I am not taking any drugs that strongly affect liver enzymes.I do not have eye melanoma.Your body has enough infection-fighting white blood cells.I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.My cancer can be measured or observed.I have had treatments like chemotherapy or immunotherapy after my main cancer treatment.My melanoma diagnosis was confirmed with a biopsy.It has been over 28 days since my last systemic therapy.It has been over 14 days since my last radiation treatment.My stage IV cancer was removed and I'm receiving additional treatment.I can carry out all my usual activities without help.I had radiotherapy and any side effects are now mild.I have never been treated with drugs that target cell growth.Your blood creatinine level is within a certain range.My melanoma is stage IV and started in the skin or mucous membranes.You do not have any tumors that have spread to your brain as shown by a CT scan or MRI.My bilirubin levels are within normal limits.Your platelet count is at least 100,000 per cubic millimeter.Your hemoglobin level is at least 9 grams per deciliter.Your SGOT or SGPT levels should not be more than 2.5 times the normal limit, or 5 times the normal limit if you have liver metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total sample size of this research program?
"Recruitment for this clinical trial has concluded. Initially posted on the 1st of July 2009 and last updated at the end of August 2022, participants are no longer being recruited to take part in it. If you're searching for other trials, there exist 759 medical studies seeking patients with acral lentiginous melanoma and 3 separate ones looking for volunteers who would use Dinaciclib as a treatment option."
Answered by AI
Has Dinaciclib been given regulatory clearance for usage?
"The safety of Dinaciclib was rated a 2 due to the limited evidence indicating its efficacy, while there is some clinical data that can attest to its security."
Answered by AI
How widely distributed is this research effort in Canada?
"This clinical investigation is currently taking place in 100 distinct sites located around the United States, including Boca Raton, Dayton and Chanute. For those interested in participating, it may be advisable to select a nearby site to minimize travel obligations."
Answered by AI
Are there opportunities for individuals to enroll in the research study currently?
"Based on the recent updates to clinicaltrials.gov, this particular trial is not currently enrolling participants. Initially posted in July 2009 and last edited in August 2022, this medical study has now been superseded by 762 other investigations actively seeking patients."
Answered by AI
What other research initiatives have been conducted utilizing Dinaciclib?
"At present, three trials are in progress for Dinaciclib with none of them at Phase 3. Majority of these studies are conducted at Salamanca, Maryland while the other 212 sites all over the world also contribute to research on this drug."
Answered by AI
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