Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

Advanced/Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01092052
• Other study ID #: CDCA-354-002
• Status: Terminated
• Phase: Phase 1
• First received: March 22, 2010
• Last updated: September 6, 2012
• Start date: January 2010

Study information

• Verified date: September 2012
• Source: Nerviano Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• 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/metastatic solid tumors.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. primary completion date: July 2012
• 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/Metastatic Solid Tumors

Intervention

Drug:
• NMS-1116354
Oral daily administration for 14 consecutive days followed by 7 days of rest

Locations

Country	Name	City	State
France	Institut Gustave-Roussy (IGR)	Villejuif, Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Nerviano Medical Sciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)		3 weeks	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)		6 weeks	No