Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.

NCT01289028 | Completed Phase 3 Results

• 2 other identifiers: CAMN107DDE052008-000357-35
• Study Type: interventional
• Target: 125
• Locations: 2 countries
• Sites: 19

Brief Summary

This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.

Conditions

Gastrointestinal Stromal Tumors

Keywords

GIST; Imatinib; Sunitinib; Gastrointestinal; Stromal; Tumors

Outcome Measures

Primary Outcomes (3)

• Percent of Patients Achieving Stable Disease (SD)

  Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.

  During the first 4 months

• Percent of Patients Achieving Partial Response (PR)

  The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

  during the first 4 months

• Percent of Patients Achieving Complete Response (CR)

  Complete response (CR) is the Disappearance of all target lesions.

  during the first 4 months

Secondary Outcomes (6)

• Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population

  24 weeks and 52 weeks

• Time to Overall Response (CR or PR): Per Protocol Population

  24 weeks and 52 weeks

• Time to Tumor Progression

  during the first 4 months

• Duration of Overall Response

  during 12 months

• Overall Survival, Number of Events Related to Progression of the Disease

  during 12 months

Study Arms (1)

Nilotinib

EXPERIMENTAL

nilotinib 400 mg twice daily (bid).

Drug: Nilotinib

Interventions

Nilotinib DRUG

Also known as: AMN107

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent.
• Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)
• At least one measurable site of disease on CT/MRI as defined by RECIST criteria.

You may not qualify if:

• Prior treatment with nilotinib.
• Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1.
• Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
• Impaired cardiac function at visit 1
• Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (19)

Novartis Investigative Site

Bad Saarow, 155226, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Düsseldorf, 40479, Germany

Location

Novartis Investigative Site

Essen, 45122, Germany

Location

Novartis Investigative Site

Frankfurt, 60488, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Halle, 06120, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Mannheim, 68167, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Taormina, ME, 98039, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Padua, PD, 35100, Italy

Location

Novartis Investigative Site

Aviano, PN, 33081, Italy

Location

Novartis Investigative Site

Torino, TO, 10153, Italy

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Neoplasms

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2011
• First Posted: February 3, 2011
• Study Start: November 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 2, 2017
• Results First Posted: November 1, 2016

Record last verified: 2016-06

Locations

DE (12); IT (7)