Conditions: Solid Tumor
Keywords: Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 34
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: CVX-060 + sunitinib arm 2: CVX-060 + sunitinib arm 3: CVX-060 + sunitinib arm 4: CVX-060 + sunitinib arm 5: CVX-060 + sunitinib arm 6: sunitinib alone

Interventions: intervention 1: CVX-060 + sunitinib intervention 2: CVX-060 + sunitinib intervention 3: CVX-060 + sunitinib intervention 4: CVX-060 + sunitinib intervention 5: CVX-060 + sunitinib intervention 6: Sunitinib
Intervention descriptions: intervention 1: CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 2: CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 3: CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 4: CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 5: CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 6: 50 mg sunitinib daily (4 out of 6 weeks)

Protocol document: