A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma

NCT00982657 | Terminated Phase 2 Results

• 3 other identifiers: B1131001CVX-060-1022010-022657-42
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 7

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).

Conditions

Solid Tumor

Keywords

Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  The MTD was defined as the dose level at which less than or equal to (\<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having \>= 2/6 participants with DLT.

  Baseline up to Cycle 1( Day 1 to Day 42)

• Progression-free Survival (PFS)

  PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.

  Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)

Secondary Outcomes (7)

• Pharmacokinetic Parameters of CVX-060

  Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)

• Number of Participants With Dose-limiting Toxicities (DLT)

  Baseline up to 28 days post last dose of study medication

• Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels

  Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)

• Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)

  Baseline up to 28 days post last dose of study medication

• Percentage of Participants With Objective Response

  Baseline up to 7 days post last dose of study medication

Study Arms (6)

Cohort 1

EXPERIMENTAL

CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Cohort 2

EXPERIMENTAL

CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Cohort 3

EXPERIMENTAL

CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Expanded cohort

EXPERIMENTAL

CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Phase II - Arm A

EXPERIMENTAL

CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Phase II - Arm B

ACTIVE COMPARATOR

sunitinib alone

Drug: Sunitinib

Interventions

CVX-060 + sunitinib DRUG

CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Also known as: CVX-060 / Sutent

Cohort 1

Sunitinib DRUG

50 mg sunitinib daily (4 out of 6 weeks)

Also known as: Sutent

Phase II - Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85258, United States

Location

Premiere Oncology, A Medical Corporation

Santa Monica, California, 90404, United States

Location

Boston Baskin Cancer Foundation

Southaven, Mississippi, 38671, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Boston Baskin Cancer Foundation

Bartlett, Tennessee, 38133, United States

Location

Boston Baskin Cancer Foundation

Germantown, Tennessee, 38138, United States

Location

Boston Baskin Cancer Foundation

Memphis, Tennessee, 38120, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

On 25 Oct 2012, due to data safety signals in separate clinical trial with CVX-060, all CVX-060 studies were discontinued. Ongoing participants in B1131001 were permitted to remain on study at a reduced dose if determined to derive clinical benefit.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 20, 2015
• Results First Posted: August 24, 2015

Record last verified: 2015-10

Locations

US (7)