Phase 2
Completed N=37
RO4929097 in Treating Patients With Metastatic Colorectal Cancer
Recurrent Colon Cancer · Recurrent Rectal Cancer · Stage IV Colon Cancer · Stage IV Rectal Cancer
Source: ClinicalTrials.gov NCT01116687 ↗
Enrolled (actual)
37
Serious AEs
36.4%
Results posted
Jun 2012
Primary outcomePrimary: Number of Participants With Objective Radiographic Response (ORR) — 0 participants
Summary
This phase II trial studies how well RO4929097 works in treating patients with metastatic colorectal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Radiographic Response (ORR) |
— | — |
| SECONDARY Participant Overall Survival (OS) Rate |
6 | — |
| SECONDARY Participant Progression Free Survival (PFS) Rate |
1.8 | — |
| SECONDARY Number of Related Serious Adverse Events (SAEs) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed colorectal cancer (NOS 10010029) with evidence of stage 4 disease (distant metastases)
- 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
- Patients must have received at least two prior lines of treatment in the metastatic setting; patients must have received 5-Fluorouracil (5-FU) or capecitabine, oxaliplatin and irinotecan, either in the adjuvant or metastatic setting; at least 4 weeks must have elapsed since prior chemotherapy or radiation therapy (6 weeks if the last regimen included mitomycin C)
- Life expectancy of greater than 3 months
- ECOG performance status = = 60%)
- Absolute neutrophil count >= 1,000/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9 g/dL
- Total bilirubin = 450 msec (male) or QTcF > 470 msec (female)
- Patients who have not recovered to < CTCAE grade 2 toxicities related to prior therapy are not eligible to participate in this study
Data sourced from ClinicalTrials.gov (NCT01116687). 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. Informational only — not medical advice.