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PARP Inhibitor, CDK Inhibitor
Veliparib + Dinaciclib for Advanced Cancers
Phase 1
Waitlist Available
Led By Geoffrey I Shapiro
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
Participants must have histologically confirmed diagnosis of a solid tumor for which no curative therapy exists
Creatinine =< 1.5 times institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two drugs, veliparib and dinaciclib, for treating patients with solid tumors that have spread. The drugs may stop the growth of tumor cells by blocking enzymes needed for cell growth.
Who is the study for?
This trial is for adults with advanced solid tumors that have spread and are not curable. Participants must have a certain level of blood counts, organ function, and no recent chemotherapy or radiation. They should be able to swallow pills, may have had prior treatments but need to recover from them, agree to use contraception if they can bear children, and provide tissue samples. People with uncontrolled illnesses or who are pregnant/nursing cannot join.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Veliparib (ABT-888) and Dinaciclib (SCH727965), which might block enzymes that help tumor cells grow. It's in phase I to find out the safest dose with the least side effects for patients whose cancer has spread widely.See study design
What are the potential side effects?
Potential side effects include issues related to cell growth inhibition such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on how well individuals tolerate these medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My solid tumor cancer cannot be cured with existing treatments.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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I haven't had chemotherapy for the last 3 weeks and have recovered from its effects.
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My hemoglobin level is above 10.0 g/dL, and I haven't had a blood transfusion in the last 28 days.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer can be measured or seen on tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase 2 dose of veliparib/dinaciclib
Secondary outcome measures
Anti-tumor activity of veliparib/dinaciclib
Change in homologous recombination deficiency (HRD) score
Changes in immunohistochemical or biochemical measurements of cyclin-dependent kinase (cdk), poly (ADP-ribose) polymerase 1 activity
+6 moreOther outcome measures
Change in BRCA1 and RAD51 expression
Change in parameters defining combined cdk and PARP inhibition
Side effects data
From 2024 Phase 3 trial • 509 Patients • NCT0216369487%
NEUTROPENIA
76%
THROMBOCYTOPENIA
76%
ANAEMIA
71%
NAUSEA
54%
ALOPECIA
50%
FATIGUE
46%
PERIPHERAL SENSORY NEUROPATHY
45%
DIARRHOEA
40%
LEUKOPENIA
36%
HEADACHE
34%
CONSTIPATION
34%
VOMITING
25%
ASTHENIA
24%
DECREASED APPETITE
24%
HYPOMAGNESAEMIA
21%
COUGH
20%
DYSPNOEA
20%
PAIN IN EXTREMITY
20%
DYSGEUSIA
19%
DIZZINESS
19%
OEDEMA PERIPHERAL
18%
BACK PAIN
18%
DYSPEPSIA
18%
INSOMNIA
18%
ARTHRALGIA
18%
EPISTAXIS
17%
MYALGIA
17%
DRUG HYPERSENSITIVITY
16%
ABDOMINAL PAIN UPPER
16%
PYREXIA
16%
NASOPHARYNGITIS
16%
ALANINE AMINOTRANSFERASE INCREASED
14%
ABDOMINAL PAIN
14%
UPPER RESPIRATORY TRACT INFECTION
14%
ASPARTATE AMINOTRANSFERASE INCREASED
13%
LYMPHOPENIA
13%
STOMATITIS
12%
HYPOKALAEMIA
12%
URINARY TRACT INFECTION
12%
BONE PAIN
11%
ANXIETY
11%
RASH
11%
HOT FLUSH
10%
DRY MOUTH
9%
PRURITUS
9%
HYPOCALCAEMIA
9%
PARAESTHESIA
9%
DEPRESSION
9%
MUCOSAL INFLAMMATION
8%
HYPOPHOSPHATAEMIA
8%
OROPHARYNGEAL PAIN
7%
DRY SKIN
7%
MUSCULOSKELETAL CHEST PAIN
7%
INFLUENZA LIKE ILLNESS
7%
VERTIGO
7%
SINUSITIS
7%
MUSCULOSKELETAL PAIN
7%
DRY EYE
7%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
LYMPHOEDEMA
6%
RHINORRHOEA
6%
DYSPNOEA EXERTIONAL
6%
TINNITUS
6%
PALPITATIONS
6%
WEIGHT INCREASED
6%
HYPERTENSION
6%
HYPERGLYCAEMIA
6%
NEUROPATHY PERIPHERAL
6%
TOOTHACHE
6%
PAIN
5%
CHEST PAIN
5%
DEHYDRATION
5%
GASTROOESOPHAGEAL REFLUX DISEASE
5%
BREAST PAIN
5%
HYPONATRAEMIA
5%
PRODUCTIVE COUGH
5%
ERYTHEMA
5%
MUSCLE SPASMS
5%
ABDOMINAL DISTENSION
5%
INFLUENZA
5%
RHINITIS
4%
MALIGNANT NEOPLASM PROGRESSION
4%
TACHYCARDIA
4%
RESPIRATORY TRACT INFECTION VIRAL
3%
FEBRILE NEUTROPENIA
2%
PNEUMONIA
1%
SEPSIS
1%
APPENDICITIS
1%
NEUTROPENIC INFECTION
1%
GASTRITIS
1%
SEIZURE
1%
ANAPHYLACTIC REACTION
1%
PULMONARY EMBOLISM
1%
CHOLELITHIASIS
1%
CELLULITIS
1%
DEVICE RELATED INFECTION
1%
ERYSIPELAS
1%
VASCULAR DEVICE INFECTION
1%
METASTASES TO MENINGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Veliparib Placebo With Carboplatin and Paclitaxel
Veliparib With Carboplatin and Paclitaxel
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (veliparib and dinaciclib)Experimental Treatment2 Interventions
PART 1A: Patients receive veliparib PO BID on days 1-28 and dinaciclib IV over 2 hours on days 8 and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PART 1B: Patients receive veliparib and dinaciclib as patients in Part 1A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PART 1C: Patients receive veliparib PO BID on days 1-7 of cycle 0. Patients then receive veliparib PO BID on days 1-21 and dinaciclib IV over 2 hours on days 1, 4, 8, and 11 or days 1 and 8. Cycles 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
Veliparib
2012
Completed Phase 3
~4820
Dinaciclib
2012
Completed Phase 3
~240
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,549 Total Patients Enrolled
Geoffrey I ShapiroPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
229 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am not pregnant or breastfeeding.I have not had a seizure in the last three months.You are allergic to lidocaine.I haven't taken any experimental drugs or immunotherapies for the last 3 weeks.I will not receive other cancer treatments except for supportive care or specific exceptions while in this study.My solid tumor cancer cannot be cured with existing treatments.I have taken cancer drugs before, but it's been a while since my last dose.I have previously been treated with SCH727965.I agree to use birth control or abstain from sex during the study.I don't have active brain metastases, and if I had them before, they've been stable for over 3 months without symptoms.I have had a bone marrow or cord blood transplant.I have previously been treated with PARP inhibitors or certain cyclin-dependent kinase inhibitors.My kidney function, measured by creatinine levels or clearance, is within the normal range.I have a BRCA1 or BRCA2 mutation, or my tumor has a BRCA mutation.I agree to skin or tumor biopsies and can pause my blood thinner medication safely if needed.I can swallow pills.I have leukemia or a pre-leukemia condition linked to previous cancer treatment.I need medication to keep my white blood cell count normal.I haven't had chemotherapy for the last 3 weeks and have recovered from its effects.My hemoglobin level is above 10.0 g/dL, and I haven't had a blood transfusion in the last 28 days.I haven't had radiation in the last 3 weeks and less than 40% of my bone marrow was treated.I am not taking strong medications that affect liver enzymes and can't switch.I agree to provide a sample of my tumor for research, if available.I can take care of myself but might not be able to do heavy physical work.You have other health conditions that the doctor thinks could affect your participation in the study, such as ongoing infections, uncontrollable vomiting, or chronic diarrhea.My cancer can be measured or seen on tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (veliparib and dinaciclib)
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.
How many individuals is the trial recruiting?
"Affirmative. According to clinicaltrials.gov, this research endeavour is currently recruiting patients that were initially posted on November 1st 2011 and recently edited on June 28th 2022. 118 participants are required for the trial at 2 different sites."
Answered by AI
Are there any opportunities remaining to join this trial?
"Affirmative. The data on clinicaltrials.gov suggests that as of June 28th 2022, this medical trial is actively recruiting and seeking 118 participants at 2 different sites; the initial posting was made November 1st 2011."
Answered by AI
What are the potential risks associated with Veliparib usage?
"There is minimal evidence of Veliparib's safety and efficacy, thus it has been assigned a score of 1."
Answered by AI
Could you provide an outline of the prior experimentation utilizing Veliparib?
"Presently, 23 clinical trials are being conducted to evaluate the efficacy of Veliparib. Of these studies, 2 have reached Phase 3. Troy Michigan is home to many of the experiments but there are over 3600 other sites across America running similar tests."
Answered by AI
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