Phase 2
N=44
RO4929097 in Treating Patients With Recurrent and/or Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Recurrent Fallopian Tube Carcinoma · Recurrent Ovarian Carcinoma · Recurrent Primary Peritoneal Carcinoma · Stage IV Fallopian Tube Cancer · Stage IV Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01175343 ↗Enrolled (actual)
44
Serious AEs
22.7%
Results posted
May 2017
Primary outcome: Primary: Four Cycle Progression-free Survival Rate — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gamma-Secretase Inhibitor RO4929097 (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Four Cycle Progression-free Survival Rate |
8 | — |
| SECONDARY Overall Response Rate |
— | — |
| SECONDARY CA125 Response Rate (GCIG Criteria) |
1 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Frequency and Severity of Adverse Events |
71; 22; 2; 19; 69; 3 | — |
| SECONDARY Expression of Notch Biomarkers in Advanced Platinum Resistant Ovarian, Fallopian, and Primary Peritoneal Cancers. |
23; 2; 6; 11 | — |
| SECONDARY Impact of RO49097 on Ascitic Fluid Circulating Tumor Cells |
— | — |
Summary
This phase II trial is studying the side effects and how well RO4929097 works in treating patients with recurrent and/or metastatic epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed ovarian epithelial carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma that is recurrent or metastatic; patients must have platinum resistant disease, as defined as treatment free interval less than 6 months post completion of platinum-based chemotherapy
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
- OR patients must have evidence of progression based on an elevated CA-125 (defined as a value of > 2 x ULN documented on two separate determinations made > 2 weeks apart, with the most recent being completed within 7 days prior to start of study treatment) if the physical exam is normal and maximum lesion diameter on the CT scan is = 4 weeks (6 weeks for nitrosoureas or mitomycin C) before study entry
- Prior radiotherapy is allowed provided that there is documented progression (either locally or systemically)
- Patients may have had up to 2 prior lines of chemotherapy for recurrent or metastatic disease
- Toxic effects from prior therapy must have resolved to grade 1 or less except for peripheral neuropathy and alopecia
- Life expectancy of greater than 12 weeks
- ECOG performance status = = 60%)
- Patients must have normal organ and marrow function as defined below (within 7 days prior to start of study treatment):
- Hemoglobin >= 90 g/L
- Leukocytes >= 3.0 x 10^9/L
- Absolute neutrophil count >= 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Total bilirubin = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (using Cockcroft-Gault Formula)
- All radiology studies must be performed = 470 msec (female), QTc > 450 msec (male)
- History of risk factors for QT interval prolongation, including, but not limited to family or personal history of long QT syndrome, recurrent syncope without known etiology or sudden unexpected death
- History of torsade de pointes or other significant cardiac arrhythmias or the need for concomitant meds with known potential to prolong QT interval or antiarrhythmics
Data sourced from ClinicalTrials.gov (NCT01175343). 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.