NCT01638546Active, not recruitingPhase 2
Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
A Multi-Center, Randomized, Double-Blind Phase II Study Comparing ABT-888, a PARP Inhibitor, Versus Placebo With Temozolomide in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
This randomized phase II trial studies how well temozolomide with or without veliparib works in treating patients with small cell lung cancer that has returned or does not respond to treatment. Temozolomide works by damaging molecules inside the cancer cells, such as deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether temozolomide is more effective with or without veliparib in treating patients with relapsed or refractory small cell lung cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 9 Jul 2012
- Start date
- 27 Jul 2012
- Primary completion date
- 9 Jan 2017
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Lung cancer
- NCT number
- NCT01638546
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 97
- From 27 Jul 2012 to the primary completion date, 9 Jan 2017
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study
- Patients who have been administered ABT-888, any other PARP-inhibitor, or temozolomide
- Patients may not be receiving any other investigational agents
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888; these potential risks also apply to temozolomide
Other illness
- Patients with active seizures or a history of seizures
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or temozolomide
- 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
- Patients with either AIDS or HIV on combination antiretroviral therapy are ineligible
- Patients with a synchronous active malignancy requiring treatment
Other
- Patients who have not recovered from adverse events due to agents administered more than 3 weeks earlier; toxicities should have resolved to baseline or to within one grade level of their baseline (not to exceed grade 2)
- Patients with leptomeningeal involvement
Who the study is looking for
- Patients must have histologically or cytologically confirmed small cell lung cancer; confirmation will be done at Memorial Sloan-Kettering Cancer Center (MSKCC) or locally for participating sites
- Patients' disease has relapsed or progressed after one or two prior chemotherapy regimens, one of which must have been an etoposide-platinum doublet; eligible patients will be defined as follows:
- "Sensitive" disease: patients who had one previous line of chemotherapy and maintained an appropriate response for \> 60 days
- "Refractory" disease: those patients with either (a) no response to first-line chemotherapy or progression =\< 60 days after completing treatment, or (b) "sensitive" or "refractory" disease in need of third-line therapy (i.e. completed or failed two previous lines of chemotherapy)
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
- Patients with asymptomatic brain metastases that do not require immediate whole brain radiation therapy and are on stable doses of steroids are allowed
- Patients must have measurable disease, which is defined as at least one lesion that can be accurately measured in at least one dimension on a computed tomography (CT) scan as per RECIST version 1.1; brain metastases can be considered measurable disease if they meet this criterion
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>= 8.5 g/dL; the use of transfusion to achieve this criterion should be at the discretion of the investigators
- Total bilirubin =\< 1.5 mg/dL x institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal
- Creatinine =\< 1.5 x institutional upper limit of normal OR creatinine clearance \>= 50 mL/min/1.73 m\^2 for patients with creatinine levels \>= 1.5 x upper limit of institutional normal
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- For women of child-bearing potential, negative pregnancy test within 14 days prior to starting temozolomide and ABT-888
- Ability to understand and the willingness to sign a written informed consent document
- Able to swallow pills
- Patients will not be excluded based on the diagnosis of acquired immune deficiency syndrome (AIDS); given the increased risk of infection, these patients should have cluster of differentiation (CD)4 counts above 200 cells/mm\^3; patients with AIDS or human immunodeficiency virus (HIV) not receiving agents with the potential for pharmacokinetic interactions with ABT-888 may be eligible
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Johns Hopkins Bayview Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| UT MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Memorial Sloan Kettering Sleepy Hollow Coordinator of this site? Confirm its status | Sleepy Hollow | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.