Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5083945 · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| KRAS WT A | EXPERIMENTAL | - |
| KRAS WT B | ACTIVE_COMPARATOR | - |
| KRAS mutant A | EXPERIMENTAL | - |
| KRAS mutant B | ACTIVE_COMPARATOR | - |
| A non-squamous | EXPERIMENTAL | - |
| A squamous | EXPERIMENTAL | - |
| B non-squamous | ACTIVE_COMPARATOR | - |
| B squamous | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| FOLFIRI | DRUG | standard iv chemotherapy |
| RO5083945 | DRUG | 1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter |
| cetuximab | DRUG | 400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week |
| cisplatin | DRUG | standard treatment, up to 6 cycles |
| gemcitabine | DRUG | standard treatment, up to 6 cycles |
| pemetrexed | DRUG | standard treatment, up to 6 cycles |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Carcinoma of the colon and/or rectum * Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease * ECOG performance status 0-1 * Adequate hematological, rena...
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RO5083945 is an investigational oncology drug studied in colorectal cancer, head and neck cancer, non-squamous non-small cell lung cancer, and other solid tumors. It has been evaluated in Phase 1 and Phase 2 clinical trials, including a Phase 2 study in metastatic colorectal cancer and a Phase 2 study in advanced or recurrent non-small cell lung cancer.
RO5083945 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical program for the drug across multiple solid tumor indications, including colorectal cancer, non-small cell lung cancer, and head and neck cancer.
RO5083945 has completed Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. Its trials include Phase 2 studies in metastatic colorectal cancer and non-squamous non-small cell lung cancer, plus Phase 1 studies in head and neck cancer and EGFR-positive solid tumors.
RO5083945 has been studied in completed trials including NCT01326000, a Phase 2 study in metastatic colorectal cancer combining RO5083945 with FOLFIRI versus FOLFIRI plus cetuximab or FOLFIRI alone; NCT01185847, a Phase 2 study in non-squamous non-small cell lung cancer; NCT01046266, a Phase 1 pharmacodynamics study in head and neck squamous cell carcinoma; and NCT00721266, a Phase 1 dose-escalation study in EGFR-positive solid tumors.
The RO5083945 clinical program enrolled patients across four completed trials. The Phase 2 metastatic colorectal cancer study NCT01326000 enrolled 169 patients, the Phase 2 non-small cell lung cancer study NCT01185847 enrolled 90, the Phase 1 head and neck cancer study NCT01046266 enrolled 62, and the Phase 1 solid tumor study NCT00721266 enrolled 102.
Yes. RO5083945 trials used biomarker selection, and the Phase 1 dose-escalation study NCT00721266 enrolled patients with metastatic and/or locally advanced malignant epidermal growth factor receptor positive solid tumors. The Phase 2 colorectal cancer study NCT01326000 was randomized and active-controlled, comparing RO5083945 plus FOLFIRI against FOLFIRI with cetuximab or FOLFIRI alone.