NCT01240655

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2011

Typical duration for phase_1

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 19, 2020

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

November 10, 2010

Last Update Submit

December 16, 2020

Conditions

Solid Tumors

Keywords

LCL161solid tumorspaclitaxel

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel

    24 months

Secondary Outcomes (4)

  • Safety and tolerability of the combination, including acute and chronic toxicities

    24 months

  • Pharmacokinetics of both LCL161 and paclitaxel when administered in combination (AUC0-∞, Cmax, tmax and other parameters as appropriate)

    24 months

  • Preliminary anti-tumor activity associated with this combination treatment

    24 months

  • Target inhibition, cell death, and cytokines in surrogate and tumor tissues

    24 months

Study Arms (1)

LCL161 + Paclitaxel

EXPERIMENTAL
Drug: LCL161Drug: Paclitaxel

Interventions

LCL161DRUG
LCL161 + Paclitaxel
PaclitaxelDRUG
LCL161 + Paclitaxel

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Dana Farber Cancer Institute SC

Boston, Massachusetts, 02215, United States

Location

University of North Carolina Lineberger Comp Cancer Ctr

Chapel Hill, North Carolina, 27514, United States

Location

Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 1L3, Canada

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Related Links

MeSH Terms

Interventions

LCL161Paclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 15, 2010

Study Start

April 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 19, 2020

Record last verified: 2016-09

Locations

US(3)ES(2)IT(1)CA(1)