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NCT00982657
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
Phase 2 trial testing CVX-060 + sunitinib in Solid Tumor in 34 participants. Terminated before completion.
1 March 2014
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 1 September 2009 |
| Primary completion | 1 March 2014 |
| Estimated completion | 1 March 2014 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- CVX-060 + sunitinib — full drug profile →
- CVX-060 + sunitinib — full drug profile →
- CVX-060 + sunitinib — full drug profile →
- CVX-060 + sunitinib — full drug profile →
- CVX-060 + sunitinib — full drug profile →
- Sunitinib (sunitinib) — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
Pfizer — full company profile →
Who can join
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum Tolerated Dose (MTD)
Time frame: Baseline up to Cycle 1( Day 1 to Day 42)
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. -
Progression-free Survival (PFS)
Time frame: Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)
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.
Sponsor's own description
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).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Ang-2/VEGF bispecific antibody reprograms macrophages and resident microglia to anti-tumor phenotype and prolongs glioblastoma survival.
Kloepper J, Riedemann L, Amoozgar Z, Seano G, et al · · 2016 · cited 296× · PMID 27044098 · DOI 10.1073/pnas.1525360113 -
Understanding and targeting resistance to anti-angiogenic therapies.
Clarke JM, Hurwitz HI. · · 2013 · cited 69× · PMID 23997938 · DOI 10.3978/j.issn.2078-6891.2013.036 -
Ang2 inhibitors and Tie2 activators: potential therapeutics in perioperative treatment of early stage cancer.
Khan KA, Wu FT, Cruz-Munoz W, Kerbel RS. · · 2021 · cited 36× · PMID 34125494 · DOI 10.15252/emmm.201708253 -
Chemically programmed antibodies.
Rader C. · · 2014 · cited 31× · PMID 24630478 · DOI 10.1016/j.tibtech.2014.02.003 -
Immunoglobulins with Non-Canonical Functions in Inflammatory and Autoimmune Disease States.
Ermakov EA, Nevinsky GA, Buneva VN. · · 2020 · cited 23× · PMID 32751323 · DOI 10.3390/ijms21155392
Verify or expand the search:
- PubMed search for NCT00982657
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00982657 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 16 October 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00982657.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing