A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
| Status: | Terminated |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | March 2014 |
A Phase Ib/ii, Multicenter, Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
The safety and tolerability of CVX-060 have been established in the first-in-human clinical
trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and
pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced
solid tumors, and to subsequently assess the treatment efficacy of the combination
treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma
(mRCC).
trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and
pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced
solid tumors, and to subsequently assess the treatment efficacy of the combination
treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma
(mRCC).
On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical
data which led to a re-assessment of the strategic goals of the PF-04856884 program. The
study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety
signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies
were discontinued and ongoing patients on B1131001 were permitted to remain on study at a
reduced PF-04856884 dose if determined to have been deriving clinical benefit.
data which led to a re-assessment of the strategic goals of the PF-04856884 program. The
study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety
signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies
were discontinued and ongoing patients on B1131001 were permitted to remain on study at a
reduced PF-04856884 dose if determined to have been deriving clinical benefit.
Inclusion Criteria:
- Histologically or cytologically confirmed advanced/metastatic solid tumor
- Having received at least 1 prior systemic therapy for the treatment of
advanced/metastatic solid tumors
- Histologically or cytologically confirmed renal cell carcinoma with clear cell
histology and evidence of metastasis (No previous systemic therapy for the treatment
of metastatic renal cell carcinoma)
- Adequate laboratory tests
- Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy > or = 12 weeks and
age > or = 18 years
Exclusion Criteria:
- Patients intolerant of prior anti-angiogenic agents
- Recent history of bleeding or bleeding disorders
- History of tumors in the brain
- History of heart problems
- History of severe allergic reaction to antibody therapy
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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