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Solid TumorPhase 2NCT00982657

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

A Phase 2 study testing CVX-060 + sunitinib and Sunitinib in people with Solid Tumor, run by Pfizer at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
CVX-060 + sunitinib and Sunitinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
7 sitesUnited States
Study dates
Sep 2009to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Boston Baskin Cancer Foundation

    Bartlett, Tennessee, 38133

  • Boston Baskin Cancer Foundation

    Germantown, Tennessee, 38138

  • Boston Baskin Cancer Foundation

    Memphis, Tennessee, 38120

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Premiere Oncology, A Medical Corporation

    Santa Monica, California, 90404

  • Premiere Oncology of Arizona

    Scottsdale, Arizona, 85258

  • Boston Baskin Cancer Foundation

    Southaven, Mississippi, 38671

Other trials in United States

About this study

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

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).

Read the 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.

Conditions
Solid Tumor
Being tested
CVX-060 + sunitinib, Sunitinib
Keywords
Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVX-060 + sunitinibDrug

    Also called CVX-060 / Sutent

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

  • CVX-060 + sunitinibDrug

    Also called CVX-060 / Sutent

    CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

  • CVX-060 + sunitinibDrug

    Also called CVX-060 / Sutent

    CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

  • CVX-060 + sunitinibDrug

    Also called CVX-060 / Sutent

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

  • CVX-060 + sunitinibDrug

    Also called CVX-060 / Sutent

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

  • SunitinibDrug

    Also called Sutent

    50 mg sunitinib daily (4 out of 6 weeks)

Study groups in NCT00982657
Study groupRoleWhat they receive
Cohort 1ExperimentalCVX-060 + sunitinib
Receives: Drug: CVX-060 + sunitinib
Cohort 2ExperimentalCVX-060 + sunitinib
Receives: Drug: CVX-060 + sunitinib
Cohort 3ExperimentalCVX-060 + sunitinib
Receives: Drug: CVX-060 + sunitinib
Expanded cohortExperimentalCVX-060 + sunitinib
Receives: Drug: CVX-060 + sunitinib
Phase II - Arm AExperimentalCVX-060 + sunitinib
Receives: Drug: CVX-060 + sunitinib
Phase II - Arm BActive comparatorsunitinib alone
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (7)

  1. Pharmacokinetic Parameters of CVX-060

    Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.

    Measured: 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)

  2. Number of Participants With Dose-limiting Toxicities (DLT)

    DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.

    Measured: Baseline up to 28 days post last dose of study medication

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

    Measured: 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)

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

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.

    Measured: Baseline up to 28 days post last dose of study medication

  5. Percentage of Participants With Objective Response

    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.

    Measured: Baseline up to 7 days post last dose of study medication

  6. Duration of Response

    Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.

    Measured: Baseline up to 7 days post last dose of study medication

  7. Number of Participants With Anti- CVX-060 Antibodies

    Measured: Baseline up to 28 days after last CVX-060 dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: Refer to statement in Summary Section/Detailed Description

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00982657
Sponsor's protocol ID
B1131001
Other IDs
CVX-060-102, 2010-022657-42
Status last verified
Oct 2015
First submitted
22 Sep 2009
Last updated
20 Nov 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CVX-060 + sunitinib and Sunitinib in people with Solid Tumor, run by Pfizer at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Baseline up to Cycle 1( Day 1 to Day 42)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00982657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

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