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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

November 10, 2010
August 21, 2014
April 2011
December 2014   (final data collection date for primary outcome measure)
Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To determine the maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01240655 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess the safety and tolerability of the combination, including acute and chronic toxicities [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics of both LCL161 and paclitaxel24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare the pharmacokinetics of paclitaxel with and without LCL161 in the PK expansion group during the dose expansion phase [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To describe any preliminary anti-tumor activity associated with this combination treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To assess target inhibition, cell death, and cytokines in surrogate and tumor tissues [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors
A Phase Ib Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
  • Drug: LCL161
  • Drug: Paclitaxel
Experimental: LCL161 + Paclitaxel
Interventions:
  • Drug: LCL161
  • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
81
December 2014
December 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Canada,   Italy,   Spain
 
NCT01240655
CLCL161A2104, 2009-015594-12
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP