Study of NMS-1116354 in Solid Tumors

• Sponsor: Nerviano Medical Sciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01016327
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 41
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: NMS-1116354	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced Solid Tumors
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: NMS-1116354; Oral daily administration for 7 consecutive days every 14 days

Outcome Measures

Primary Outcome Measures

1. First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD) [Cycle 1]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Nerviano Medical Sciences

Investigators

• Principal Investigator: Kyriakos Papadopoulos, MD, MSc, South Texas Accelerated Research Therapeutics (START)
• Study Director: Bernard Laffranchi, MD, Nerviano Medical Sciences
• Study Director: Stefania Crippa, Biotech D, PhD, Nerviano Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nerviano Medical Sciences
• ClinicalTrials.gov Identifier: NCT01016327
• Other Study ID Numbers: CDCA-354-001
• First Posted: Nov 19, 2009
• Last Update Posted: Sep 7, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Nerviano Medical Sciences: Phase I study; Advanced Solid Tumors; Cdc7 kinase inhibitor
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Sep 7, 2012