Overview

Study of NMS-1116354 in Solid Tumors

Status:
Terminated
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nerviano Medical Sciences
Criteria
Inclusion Criteria:

1. Advanced/metastatic solid tumors, for which no alternative effective standard therapy
is available

2. Maximum of 4 regimens of prior cancer therapy allowed

3. Prior radiotherapy allowed if no more than 25% of BM reserve irradiated

4. Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer
therapy

5. ECOG performance status (PS) 0 or 1

6. Adult (age >/= 18 and
7. Adequate renal, liver and BM reserve

8. Capability to swallow capsules intact

Exclusion Criteria:

1. Current enrollment in another therapeutic clinical trial

2. Known brain metastases

3. Currently active second malignancy

4. Major surgery within 4 weeks prior to treatment

5. Any of the following in the past 6 months: myocardial infarction, unstable angina,
coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein
thrombosis

6. Pregnancy or breast-feeding women

7. Known active infections

8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug
absorption

9. Adrenal insufficiency

10. Other severe acute or chronic medical or psychiatric condition that could compromise
protocol objectives