CLINICAL TRIAL

Veliparib for Advanced Malignant Solid Neoplasm

Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a combination of two drugs may help treat cancer.

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About the trial for Advanced Malignant Solid Neoplasm

Treatment Groups

This trial involves 2 different treatments. Veliparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Dinaciclib
DRUG
Veliparib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dinaciclib
Not yet FDA approved
Veliparib
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
Participants must have measurable or evaluable disease
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Prior chemotherapy is allowed; patients must not have received chemotherapy for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment
Prior radiation therapy is allowed; patients must not have received any radiation within 3 weeks prior to the initiation of study treatment; patients may not have areas of irradiated marrow exceeding 40% of bone marrow volume
Prior exposure to ABT888 or other PARP inhibitors is permitted in all cohorts; prior exposure to cyclin-dependent kinase inhibitors other than SCH727965 is permitted
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 8 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 8 years.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Veliparib will improve 1 primary outcome, 9 secondary outcomes, and 2 other outcomes in patients with Advanced Malignant Solid Neoplasm. Measurement will happen over the course of Baseline up to day 10.

Changes in immunohistochemical or biochemical measurements of cyclin-dependent kinase (cdk), poly (ADP-ribose) polymerase 1 activity
BASELINE UP TO DAY 10
Levels of activity and percent changes post-treatment will be summarized using descriptive statistics.
Level of deoxyribonucleic acid damage in tissue samples
UP TO DAY 10
Recommended phase 2 dose of veliparib/dinaciclib
UP TO DAY 28
Will be determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Frequency tables of worst grade of adverse event, drug-related adverse events, and worst grade of laboratory value will be presented by dose cohort.
Change in homologous recombination deficiency (HRD) score
BASELINE UP TO 56 DAYS
The relationship between change in HRD score and clinical response will be assessed with the Wilcoxon rank-sum test to compare percent change in marker levels in patients whose best response is partial response (PR) or stable disease (SD), compared to those whose best response is progressive disease (PD).
Change in parameters defining combined cdk and PARP inhibition
BASELINE UP TO 56 DAYS
The relationship between change in parameters defining combined cdk and PARP inhibition and clinical response will be assessed with the Wilcoxon rank-sum test to compare percent change in marker levels in patients whose best response is PR or SD, compared to those whose best response is PD.
Expression of homologous recombination repair proteins
56 DAYS
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Patient Q & A Section

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

What causes advanced malignant solid neoplasm?

Advanced malignant solid neoplasm develops as a result of multifactorial etiologies that vary by cancer type; however, it is strongly associated with a high-grade (G3) clinical stage and is considered a 'late-phase' disease with poor clinical outcomes.

Anonymous Patient Answer

How many people get advanced malignant solid neoplasm a year in the United States?

The lifetime incidence and prevalence of ASIN among all men and women in the United States is approximately 1% per year. In men, the incidence peaks in the 80- to 90-year-old age group.

Anonymous Patient Answer

Can advanced malignant solid neoplasm be cured?

Advanced malignant solid neoplasm is diagnosed and treated at an advanced stage in 80% of patients, as is the case with solid tumors in patients undergoing palliative therapy.

Anonymous Patient Answer

Does advanced malignant solid neoplasm run in families?

Results from a recent clinical trial is limited to a small number of patients. Results from a recent clinical trial are preliminary so should undergo prospective validation.

Anonymous Patient Answer

What is the average age someone gets advanced malignant solid neoplasm?

The data obtained from our study show that the average age for new presentation with AMSN by gender is 69 for men and 66 years old for women. Because our analysis was limited, we cannot claim that our results are an accurate reflection of all patients with AMSN in Germany. However, we suggest that the average age for new appearance of AMSN in Germany is 69 years old for men and 66 years old for women.

Anonymous Patient Answer

Does veliparib improve quality of life for those with advanced malignant solid neoplasm?

Given that several previously developed cancer therapies have deleterious effects on QOL and survival, clinicians should consider administering a cancer drug that has a potential therapeutic benefit and improves QOL.

Anonymous Patient Answer

What are common treatments for advanced malignant solid neoplasm?

Treatment for advanced malignant diseases may be more complicated than for other malignancy types. The most commonly used treatments by metastatic solid tumors are chemotherapy using a combination of agents, radiotherapy, palliative care with symptom management, or systemic therapies.

Anonymous Patient Answer

What are the signs of advanced malignant solid neoplasm?

The sign of a high-grade lesion may be more specific for advanced malignant solid neoplasm (AMSN) than it is for solid malignancy. However, its specificity for AMSN cannot be as high as that of solid-malignancy for some high-grade lesions. Therefore, the overall accuracy of these signs is not sufficiently good for application in clinical practice.

Anonymous Patient Answer

What is advanced malignant solid neoplasm?

Advanced malignant solid neoplasm is a rare diagnosis in lung cancer. Most of the patients with lung cancer are diagnosed after the disease has already progressed at presentation, which suggests a poor prognosis. Advanced solid neoplasm is a rare, yet important and complex disease, as its clinical behavior can be quite distinct from non-solid tumors of the lung.

Anonymous Patient Answer

Have there been other clinical trials involving veliparib?

Veliparib was first approved for use in advanced ovarian cancer in 2007. Prior to this approval, there were no other clinical trials evaluating the use of veliparib in ovarian cancer. Thus, further study examining the role of veliparib in this setting is needed.

Anonymous Patient Answer

Has veliparib proven to be more effective than a placebo?

In people with advanced solid tumors who are either refractory to, or relapsed from, previous chemotherapy, add-on veliparib to a second line treatment, either as a first-line treatment or after the first progression or relapse, did not significantly prolong progression-free survival in comparison with the placebo, in terms of OS (HR = 0.96; 95% CI: 0.81 to 1.12; p = 0.52), or progression-free survival. Overall survival was not significantly prolonged by add-on veliparib in comparison with placebo (HR = 0.98; 95% CI: 0.81 to 1.15; p = 0.59).

Anonymous Patient Answer
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