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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016014-25 |
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This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is <100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5323441 | Drug | cohorts receiving multiple doses iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI | up to 19.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of within-patient dose escalation | from baseline to Day 127 (+/-3) | |
| Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility) | up to 19.5 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leuven | 3000 | Belgium | ||||
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C569915 | TB-403 |
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| Candidate biomarkers associated with PD effect of RO5323441 |
| up to 19.5 months |
| Pharmacokinetics: maximum and trough concentrations of RO5323441 | up to 19.5 months |
| Safety and tolerability: Adverse events, vital signs, laboratory parameters | up to 19.5 months |
| Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments | up to 19.5 months |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Manchester | M20 4QL | United Kingdom |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |