A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Solid Tumor
Intervention: CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); Sunitinib (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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).
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum Tolerated Dose (MTD)Progression-free Survival (PFS)
Secondary outcome: Pharmacokinetic Parameters of CVX-060Number of Participants With Dose-limiting Toxicities (DLT) Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) Percentage of Participants With Objective Response Duration of Response Number of Participants With Anti- CVX-060 Antibodies
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Premiere Oncology of Arizona, Scottsdale, Arizona 85258, United States
Premiere Oncology, A Medical Corporation, Santa Monica, California 90404, United States
Boston Baskin Cancer Foundation, Southaven, Mississippi 38671, United States
Providence Portland Medical Center, Portland, Oregon 97213, United States
Boston Baskin Cancer Foundation, Bartlett, Tennessee 38133, United States
Boston Baskin Cancer Foundation, Germantown, Tennessee 38138, United States
Boston Baskin Cancer Foundation, Memphis, Tennessee 38120, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2009
Last updated: July 24, 2015
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