Trial record 1 of 3 for:    TKM-080301
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A Study to Determine Safety, Pharmacokinetics and Pharmacodynamics of Intravenous TKM 080301 in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Tekmira Pharmaceuticals Corporation
Sponsor:
Information provided by (Responsible Party):
Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01262235
First received: December 15, 2010
Last updated: May 27, 2014
Last verified: May 2014

December 15, 2010
May 27, 2014
December 2010
May 2014   (final data collection date for primary outcome measure)
  • Safety and tolerability of treatment with TKM-080301 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01262235 on ClinicalTrials.gov Archive Site
  • Characterize the pharmacokinetics of TKM-080301 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Assess preliminary evidence of anti-tumor activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Determine Safety, Pharmacokinetics and Pharmacodynamics of Intravenous TKM 080301 in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors

This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Neuroendocrine Tumors
  • NET
  • Adrenocortical Carcinoma
  • ACC
Drug: TKM-080301
Repeat dose IV infusion.
Other Names:
  • PLK1 SNALP
  • TKM-PLK1
Experimental: TKM-080301
Intervention: Drug: TKM-080301
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
June 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy.
  • Patient has an ECOG performance status of 0 - 1,
  • Patient has adequate hematologic, hepatic and renal function,
  • Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV),
  • Patients must have a life expectancy of at least 12 weeks.

Exclusion Criteria:

  • Unresolved toxicities (> Grade 1) of previous chemotherapy,
  • Patients with primary tumors of the central nervous system (CNS),
  • Prophylactic hematologic growth factors administered </= 2 weeks prior to start of therapy,
  • Patient has history of or existing clinically significant cardiovascular disease,
  • Patient has a history of clinically significant asthma or COPD requiring daily medication within the last 6 months,
  • Patient has a seizure disorder not controlled on medication,
  • Patient has a known or suspected viral, parasitic, or fungal infection,
  • Patient has known hypersensitivity or previous severe reactions to oligonucleotide- or lipid-based products, including liposomal drug products and phospholipid-based products,
  • Patient has been treated with any investigational drugs, biologics, or devices within 28 days prior to study treatment.
Both
18 Years and older
No
Contact: Lynn Murray, B.Sc. 604-419-3252 lmurray@tekmirapharm.com
Contact: Lesley Parker, B.Sc. 604-419-3214 lparker@tekmirapharm.com
United States
 
NCT01262235
TKM-PLK1-001
Yes
Tekmira Pharmaceuticals Corporation
Tekmira Pharmaceuticals Corporation
Not Provided
Study Director: Mark Kowalski, MD Tekmira Pharmaceuticals
Tekmira Pharmaceuticals Corporation
May 2014

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