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Phase 2 N=52 Treatment

Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

BRCA1 Mutation Carrier · BRCA2 Mutation Carrier · Ovarian Epithelial Tumor · Recurrent Fallopian Tube Carcinoma · Recurrent Ovarian Carcinoma

Enrolled (actual)
52
Serious AEs
20.0%
Results posted
Mar 2019
Primary outcome: Primary: Proportion of Patients With Complete and Partial Tumor Response — 0.26 Proportion of patients

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Laboratory Biomarker Analysis (Other); Veliparib (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Patients With Complete and Partial Tumor Response
0.26
PRIMARY
Proportion of Patients With Adverse Events as Assessed by CTCAE v4.0
0.32
SECONDARY
Duration of PFS
8.18
SECONDARY
Duration of OS
NA
SECONDARY
The Proportion of Patients Who Survive Progression-free for at Least 6 Months
0.54

Summary

This phase II trial studies how well veliparib works in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma AND carry a germline mutation in BRCA1 or BRCA2 (confirmation required via Myriad test report); histologic documentation of the original primary tumor is required via the pathology report
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors(RECIST)1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients who have received one prior cytotoxic regimen must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2
  • Patients who have received two or three prior cytotoxic regimens must have a GOG performance status of 0 or 1
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
  • Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration; patients receiving nitrosoureas or mitomycin C must discontinue 6 weeks prior to registration
  • Any prior radiation therapy must be discontinued at least four weeks prior to registration
  • Prior therapy
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy administered after surgical or non-surgical assessment
  • Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease
  • Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy for management of recurrent or persistent disease; patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen
  • Patients with both platinum-sensitive and platinum-resistant disease are eligible; patients with platinum-refractory disease are NOT eligible
  • Definitions:
  • Platinum sensitive ovarian cancer is defined as patients who respond to platinum-based therapy (complete or partial) and then progress/recur more than 6 months after their last platinum dose (i.e., platinum-free interval is > 6 months)
  • Platinum resistant ovarian cancer is defined as patients who respond to platinum-based therapy (complete or partial) and then progress/recur within 6 months of their last platinum dose (i.e., platinum-free interval is = 3 months after treatment and off steroid treatment prior to study enrollment
  • Inability or unwillingness to swallow pills
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who require parenteral hydration or nutrition
  • Patients who are pregnant or nursing
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01540565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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