CLINICAL TRIAL

Veliparib for Cancer

1 Prior Treatment
Locally Advanced
Metastatic
Refractory
Relapsed
Waitlist Available · 18+ · All Sexes · Dallas, TX

This study is evaluating whether veliparib and topotecan hydrochloride can be safely given together to treat patients with solid tumors, ovarian cancer that has come back or does not respond to treatment, or primary peritoneal cancer.

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About the trial for Cancer

Eligible Conditions
Metastatic Malignant Solid Neoplasm · Recurrent Primary Peritoneal Carcinoma · Neoplasms · Recurrent Ovarian Carcinoma · Carcinoma · Recurrent Fallopian Tube Carcinoma · Unresectable 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 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pharmacogenomic Study
OTHER
Laboratory Biomarker Analysis
OTHER
Pharmacological Study
OTHER
Topotecan Hydrochloride
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
Topotecan
FDA approved
Veliparib
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or one of the other 6 conditions listed above. 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:
that is platinum-resistant or platinum-sensitive with disease progression on or within 12 months of completing frontline chemotherapy or who have failed two or more prior lines of platinum-based chemotherapy show original
People who have not responded to treatment with three different types of chemotherapy drugs within a year of each other are eligible to participate in this study show original
SGPT (alanine aminotransferase) or serum glutamic oxaloacetic transaminase (SGOT) is less than 2.5 times the upper limit of the laboratory normal range in the absence of hepatic metastasis and less than 3 times the upper limit of the laboratory normal range or less than 5 times the upper limit of the laboratory normal range in the presence of hepatic metastasis. show original
Patients must have measurable disease with at least one lesion whose longest diameter is accurately measured as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments. show original
The total bilirubin level is less than 1.5 times the upper limit of normal. show original
are eligible for the study Patients with advanced cancers that have spread and are not able to be surgically removed are eligible to participate in this study show original
The text states that if a person's absolute neutrophil count is 1500/mcL or greater, they are diagnosed with leukemia. show original
Hemoglobin >= 9.0 g/dL
Platelets >= 100,000/mcL
Creatinine =< 1.5 x ULN
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
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 2 primary outcomes and 5 secondary outcomes in patients with Cancer. Measurement will happen over the course of 4 weeks.

Maximum tolerated dose of topotecan hydrochloride and veliparib, determined according to incidence of dose-limiting toxicity, graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
4 WEEKS
The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized. The grade 3+ adverse events will also be described and summarized in a similar fashion. Toxicity incidence by BRCA mutation will also be evaluated for the patients enrolled in the expanded Phase I maximum tolerated dose cohort. Frequency distribution, graphical techniques, and other descriptive measures will form the basis of these analyses.
4 WEEKS
Proportion of tumor responses, defined as complete response or partial response as assessed using Response Evaluation Criteria In Solid Tumors
UP TO 48 WEEKS (12 COURSES)
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987).
UP TO 48 WEEKS (12 COURSES)
Time to treatment failure
THE TIME FROM THE DATE OF REGISTRATION TO THE DATE AT WHICH THE PATIENT IS REMOVED FROM TREATMENT DUE TO PROGRESSION, ADVERSE EVENTS, OR REFUSAL, ASSESSED UP TO 5 YEARS
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
THE TIME FROM THE DATE OF REGISTRATION TO THE DATE AT WHICH THE PATIENT IS REMOVED FROM TREATMENT DUE TO PROGRESSION, ADVERSE EVENTS, OR REFUSAL, ASSESSED UP TO 5 YEARS
Progression free survival
THE TIME FROM REGISTRATION TO THE EARLIEST DATE OF DOCUMENTATION OF DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 5 YEARS
The distribution of progression free survival will be estimated using the method of Kaplan-Meier.
THE TIME FROM REGISTRATION TO THE EARLIEST DATE OF DOCUMENTATION OF DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 5 YEARS
Overall survival
THE TIME FROM REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 5 YEARS
The distribution of survival time will be estimated using the method of Kaplan-Meier.
THE TIME FROM REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 5 YEARS
Adverse events, graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
UP TO 5 YEARS
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
UP TO 5 YEARS
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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.

How many people get cancer a year in the United States?

The cancer incidence in the United States is in approximate concordance with previously published estimates and can likely be accurately projected within a reasonable time frame for the U.S. and other Western nations.

Anonymous Patient Answer

What causes cancer?

Cancer is not solely a reflection of external causes, such as pollution, chemical exposure, and lifestyle choices. Many internal factors such as genetic susceptibility, as well as environmental factors in childhood are necessary for cancer to develop.

Anonymous Patient Answer

What is cancer?

In Canada, nearly 100,000 deaths from cancer occurred in 2009, making it the leading cause of death for people aged 15 and older and the 4th leading cause of death overall. More than half the cases were attributable to lung cancer.\n

Anonymous Patient Answer

What are common treatments for cancer?

Most treatments are used very commonly, even by the most unusual or unusual treatment users. However, some are not used by many users. The use of unconventional or unusual treatments may thus be associated with unique psychological and social needs.

Anonymous Patient Answer

What are the signs of cancer?

Even though a cancer has already originated, the signs and symptoms that are present are not necessarily obvious during a routine physical exam, even when the cancer is small.

Anonymous Patient Answer

Can cancer be cured?

The incidence and mortality of several cancers can be markedly reduced. Cancer can be prevented in many cases. There is no guarantee of curing cancer, but patients with metastatic and nonmetastatic cancers can live longer and healthier lives than those with no and only early stage cancers. Treatment options are limited but can provide meaningful improvements in many people.

Anonymous Patient Answer

What is the primary cause of cancer?

There is a need for a proper explanation of the primary causes of cancer that is understandable from a layman’s point of view. The disease, a malady which is found everywhere in the world and presents with a wide variety of symptoms, may manifest a different disease at different times in the life of specific individuals only. There are a multitude of possible causes with unknown triggers and interactions. Therefore it is important to understand the mechanism for cancer and its possible causes if the disease is to be cured in the future.

Anonymous Patient Answer

What is the latest research for cancer?

Cancer-related research is often focused on finding cures rather than understanding the causes. For example, recent publications often speculate on the possibility of a cure, but rarely focus on the more difficult problems like understanding how cancer can grow in the first place. There is an urgent need to identify molecular targets for cancer therapies in order to save lives and reduce the burden of cancer as a chronic disease.

Anonymous Patient Answer

What are the chances of developing cancer?

Cancer is an ever-increasing complication of the human body’s continual state of change - including the aging process, the accretion of extra-cellular body matter, and dietary factors. So what are the chances? It is difficult to predict the prevalence or emergence of a given cancer in an individual because the development of the actual cancer involves many unknown processes. What we can do, in fact, is estimate the odds, or to put it differently, what the best time to start developing a given cancer is. The most basic fact for a rational person is that the body always has a natural ‘defense mechanism’ against cancer: a continual natural regeneration on the cellular and physiological level.

Anonymous Patient Answer

Is veliparib typically used in combination with any other treatments?

The average duration of vELP in these 5 trials was 21 weeks. The average duration of vELP as monotherapy was 37 weeks and the average duration of vELP with additional chemotherapy and antiemetics was 39 weeks. This supports the current and expected combination use of (veliparib + chemotherapy/antiemetics) as an effective treatment for patients with gB-NS-C.

Anonymous Patient Answer

How does veliparib work?

Veliparib inhibits the expression of Pgp and ABCG2 for the purpose of targeting malignant cells to the cancerous/lesions. Thus, it can be said that these proteins function similarly and are therefore the most important regulators of malignant cells as well as a common target of therapeutic drugs.

Anonymous Patient Answer
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