A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01240655
First received: November 10, 2010
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

This is a dose escalation study that will assess the safety and efficacy of LCL161 in combination with weekly paclitaxel in adult patients with advanced solid tumors.


Condition Intervention Phase
Solid Tumors
Drug: LCL161
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability of the combination, including acute and chronic toxicities [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of both LCL161 and paclitaxel when administered in combination (AUC0-∞, Cmax, tmax and other parameters as appropriate) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Preliminary anti-tumor activity associated with this combination treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Target inhibition, cell death, and cytokines in surrogate and tumor tissues [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 81
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCL161 + Paclitaxel Drug: LCL161 Drug: Paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with breast cancer must have a histologically or cytologically confirmed diagnosis of disease that has metastasized or is resistant to therapy.

Patients with ovarian cancer must have histological evidence of recurrent epithelial ovarian, fallopian tube or peritoneal cancer.

Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia Male or female patients 18 years or older ECOG performance status 0-1 Life expectancy greater than 12 weeks Measurable disease as determined by RECIST v1.0 Patients must give written informed consent and comply with the protocol

Exclusion Criteria:

For patients with breast cancer:

Concurrent Her2-directed or anti-estrogen therapy

For patients with ovarian cancer:

Primary refractory disease, defined as progression during initial treatment with a platinum- and taxane-containing regimen.

Prior treatment with weekly paclitaxel. More than two chemotherapy regimens given in the relapse setting. Evidence of a documented bowel obstruction within six months of study entry Patients with unresolved peripheral neuropathy, nausea, vomiting, or diarrhea ≥ CTCAE Grade 2 Any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities.

Patients with impairment of GI function or GI disease that may significantly alter the absorption of LCL161 Patients who have undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of procedure.

Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive β-HCG laboratory test (> 5 mIU/mL).

Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C (HIV and hepatitis testing are not mandatory).

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240655

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Massachusetts
Dana Farber Cancer Institute SC Completed
Boston, Massachusetts, United States, 02115
United States, North Carolina
University of North Carolina Lineberger Comp Cancer Ctr Completed
Chapel Hill, North Carolina, United States, 27514
United States, Tennessee
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2) Completed
Nashville, Tennessee, United States, 37203
Canada, British Columbia
Novartis Investigative Site Recruiting
Vancouver, British Columbia, Canada, V5Z 1L3
Italy
Novartis Investigative Site Recruiting
Modena, MO, Italy, 41100
Spain
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01240655     History of Changes
Other Study ID Numbers: CLCL161A2104, 2009-015594-12
Study First Received: November 10, 2010
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Spain: Agencia española de medicamento y productos sanitarios

Keywords provided by Novartis:
LCL161
solid tumors
paclitaxel

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014