Table 2.
Ongoing/pending trials of vandetanib in NSCLC
| Sponsor/trial | Phase | Target N | Eligibility | Treatment | Primary endpoint |
|---|---|---|---|---|---|
| AstraZeneca52 ZEPHYR NCT00404924 |
III | 930 | – Prior treatment with an EGFR TKI and up to 2 chemo regimens | 1. BSC + V 300 2. BSC |
OS |
| AstraZeneca53 NCT00753714 |
RII | 122 | – No prior
chemo – ≥70 years of age |
1. gemcitabine +V
100 2. gemcitabine |
PFS |
| PrECOG, LLC.54 NCT00687297 |
RII | 160 | – No prior therapy for advanced NSCLC | 1. Docetaxel/carboplatin/V 100
+ maintenance V 300 2. Docetaxel/carboplatin/V 100 |
PFS |
| AstraZeneca55 NCT00777179 |
RII | 126 | – No POD after 4 cycles of gemcitabine/cisplatin for advanced NSCLC | 1. Maintenance V 300 2. Placebo |
PFS |
| MD Anderson56 NCT00745732 |
I/II | 48 | – Inoperable/unresectable NSCLC, not candidate for chemo | Escalating doses of V starting at 100 mg + thoracic irradiation | MTD |
| AstraZeneca57 NCT00807170 |
I | 18 | – Untreated brain metastases | V 100/200/300 + WBRT | MTD |
| MD Anderson58 BATTLE NCT00410189 |
II | 72 | – At least one prior chemo for advanced NSCLC | V 300 (biomarker directed) | PFS |
| MD Anderson59 NCT00402896 |
II | 25 | – Symptomatic recurrent pleural effusion | V 300 | Time until removal of pleurex catheter |
| Simmons Cancer Center60 NCT00975260 *Not yet open |
R I/II | 72 | Stage IIIA/B NSCLC | 1. Definitive CRT with
carboplatin/paclitaxel + V followed by maintenance
V 2. Definitive CRT with carboplatin/paclitaxel |
OS |
| Karmanos Cancer Institute 61 NCT00459121 |
II | 15 | Clinical Stage IB, II, and T3N1 NSCLC | Neoadjuvant carboplatin/paclitaxel + V | Complete resection
(R0) *trial completed, awaiting results |
| AstraZeneca62 NCT00496275 |
I | 17 | Chemonaive advanced disease | Cisplatin/gemcitabine/V Cisplatin/vinorelbine/V |
Safety *trial completed, awaiting results |
Abbreviations: N, number of patients; EGFR, epidermal growth factor receptor; TKI, tyrosine kinase inhibitor; BSC, best supportive care; V, vandetanib given once daily; R, randomized; POD, progression of disease; PFS, progression-free survival; MTD, maximum tolerated dose; WBRT, whole brain irradiation; CRT, chemoradiation; OS, overall survival.