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New drug combo shows promise in battling recurrent ovarian cancer

NCT ID NCT01012817

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tested a combination of two drugs, veliparib and topotecan, in 88 patients with solid tumors or ovarian cancer that returned after initial treatment. The goal was to find the safest dose and see how well the drugs shrink tumors. While the treatment aims to control the cancer, it is not a cure, and patients may need ongoing therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

88 people

The number who actually took part.

Started

Nov 2009

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PHASE I: Adult patients with histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative measures or other therapy definitely capable of extending life expectancy does not exist * PHASE II: All patients enrolled in the Phase II portion of this trial must have a history of biopsy-proven ovarian, fallopian tube or primary peritoneal cancer * Patients must have received \< 3 lines of prior therapy and have relapsed less than a year from their last platinum regimen; regimens that are used twice (for example carboplatin and paclitaxel) can be counted as one; if a regimen is changed during the course of treatment due to side effect profile or allergy, the course of therapy is counted as one regimen; (for example, if docetaxel is substituted for paclitaxel due to a reaction during the initial course of adjuvant therapy, this is considered one regimen) * Patients must have measurable disease with at least one lesion whose longest diameter can be accurately measured as \>= 2.0 cm with conventional techniques or as \>= 1.0 cm with spiral computed topography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments * Absolute neutrophil count \>= 1500/mcL * Hemoglobin \>= 9.0 g/dL * Platelets \>= 100,000/mcL * Total bilirubin =\< 1.5 x the upper limit of normal (ULN) * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 x ULN in the absence of hepatic metastasis; SGPT (ALT) =\< 3 x ULN or SGOT (AST) =\< 5 x ULN in the presences of hepatic metastasis * Creatinine =\< 1.5 x ULN * International normalized ratio (INR) =\< 1.4 unless receiving therapeutic doses of coumadin * Partial thromboplastin time (PTT) =\< 48 seconds (1.25 x ULN) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Ability to provide informed consent * Willingness to return to enrolling institution for follow up * Life expectancy \>= 12 weeks * Willingness to provide the biologic specimens is required by the protocol; this is part of the mandatory correlative research component; these specimens include: * PHASE I: peripheral blood for plasma pharmacokinetic analysis and peripheral blood mononuclear cell (PBMC) polymer assessment from 0-24 h after drug administration on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; urine for assessment of ABT-888 renal clearance for 24 h after administration of drugs on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; and a pretreatment peripheral blood sample for possible sequencing of the BRCA1, BRCA2 loci as well as possible pharmacogenomic analysis * Negative urine or serum pregnancy test done =\< 7 days prior to registration for females of child bearing potential only * Able to swallow and absorb the medication Exclusion Criteria: * Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy * Prior treatment with a PARP inhibitor or topotecan * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Any of the following prior therapies: * Chemotherapy =\< 4 weeks prior to registration * Mitomycin C/nitrosoureas =\< 6 weeks prior to registration * Immunotherapy =\< 4 weeks prior to registration * Biologic therapy =\< 4 weeks prior to registration * Radiation therapy =\< 4 weeks prior to registration * Radiation to \> 25% of bone marrow * Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) =\< 4 weeks prior to registration; subjects with prostate cancer will be permitted to continue hormone therapy * Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * New York Heart Association classification III or IV * Known central nervous system (CNS) metastases or seizure disorder; patients with known brain metastases that have been successfully treated and stable for \>= 6 months without requirement for corticosteroids and without seizure activity will be eligible * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy, except non-melanotic skin cancer or carcinoma-in-situ of the cervix * Note: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer * History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * More than 2 prior chemotherapy regimens for the current malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy * Note: Prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) and immunotherapy will be allowed and not included as a prior chemotherapy; if the chemotherapy regimen is altered during the course due to issues with tolerability or safety, the regimen will be counted as one; using the same regimen at recurrence is counted as one regimen; the addition of bevacizumab to a prior regimen is considered one regimen

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Parkland Memorial Hospital

    Dallas, Texas, 75235, United States

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451, United States

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462, United States

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

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