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Veliparib and Dinaciclib in Treating Patients With Advanced Solid Tumors

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01434316 (View complete trial on
DFCI Protocol ID: 11-144


This phase I trial studies the side effects and the best dose of veliparib and dinaciclib given together with or without carboplatin and to see how well they work in treating patients with advanced solid tumors. Veliparib and dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving veliparib and dinaciclib with or without carboplatin may kill more tumor cells


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623,

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of a solid tumor for which no standard or curative therapy exists or for which standard therapy is no longer effective - Measurable or evaluable disease - Eligible patients in the dose-escalation phases of the trial must agree to biopsies of normal skin, unless they undergo optional tumor biopsies and patients enrolled to the expanded cohorts must agree to tumor sampling - Patients on anticoagulation must be able to hold warfarin or low molecular weight heparin for a sufficient amount of time to make skin and tumor biopsies safe to perform - PT/INR and PTT should be ≤ 1.5 times the institutional upper limit of normal prior to performance of skin or tumor biopsies, with values re-checked after the eligibility screen as medically indicated - Patients enrolling in the BRCA-deficient cohort must have a documented BRCA1 or BRCA2 germline mutation - All patients must agree to provide an archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies; however, patients are not considered ineligible if archival tumor is not available - Patients with known active brain metastases are excluded - Patients with a history of CNS metastases that have been treated must be stable with no symptoms for > 3 months after completion of that treatment and off steroid treatment, with image documentation required prior to study enrollment PATIENT CHARACTERISTICS: - See Disease Characteristics - ECOG performance status ≤ 2 - Absolute neutrophil count ≥ 1,500/mm^3 - Hgb > 9.0 g/dL - Platelet count ≥ 100,000/mm^3 - Total bilirubin < 1.5 mg/dL - AST (SGOT)/ALT (SGPT) ≤ 2.5 times the institutional upper limit of normal (ULN) (for patients with known liver metastases, AST and ALT ≤ 5 times ULN) - Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min - PT/INR and PTT ≤ 1.5 times ULN - Women of childbearing 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 - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with veliparib (ABT-888) and dinaciclib (SCH727965) - Patients must be able to swallow pills - Patients enrolling in Part 2 are excluded if they have a known allergy to platinum drugs (cisplatin or carboplatin) - No patients with other medical conditions judged by the investigator to be clinically relevant in the setting of this study, which may include active infectious processes, intractable emesis, or chronic diarrheal disease - No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements - No patients with active seizure or a history of seizure - No patients with a known allergy to lidocaine PRIOR CONCURRENT THERAPY: - See Disease Characteristics - 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 exposure to approved receptor tyrosine kinase inhibitors is permitted - At least 5 half-lives must have elapsed since the completion of the kinase inhibitor and the initiation of study treatment - 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 experimental (non-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 - Prior exposure to veliparib (ABT-888) or other PARP inhibitors is permitted - Prior exposure to cyclin-dependent kinase inhibitors other than dinaciclib (SCH727965) is permitted - Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e., megestrol acetate, bisphosphonates) - Men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists - No patients requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g., Neulasta®, Neupogen®) - No patients who have previously received SCH727965 - Patients on a potent CYP3A4 inhibitor or CPY3A4 inducer who cannot be changed to another medication are excluded
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