Study of NMS-1116354 in Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01016327
• Other study ID #: CDCA-354-001
• Status: Terminated
• Phase: Phase 1
• First received: November 17, 2009
• Last updated: September 6, 2012
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Nerviano Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 </= 80 years) patients

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• NMS-1116354
Oral daily administration for 7 consecutive days every 14 days

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nerviano Medical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD)		Cycle 1	Yes
Secondary	Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½)		Cycles 1 and 2	No