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TTP607 in Refractory Solid Malignancies

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
TransTech Pharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00939172
First received: July 10, 2009
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of TTP607 that can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be studied.

Researchers will also do pharmacokinetic (PK) testing of TTP607. PK testing measures the amount of a drug in the body at different time points.


Condition Intervention Phase
Advanced Cancers
Lymphoma
Drug: TTP607
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Phase I, Single Group Assignment Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TTP607 Administered in Cycles of Five Daily One to Four Hour Infusions to Patients With Advanced Refractory Solid Malignancies

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: End of each 15 day cycle ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2010
Arms Assigned Interventions
Experimental: TTP607 Drug: TTP607
3.3 mg/m^2 given by central venous catheter over 1-4 hours, each day for 5 days in a row, for a 15 day cycle.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

Inclusion:

  1. Patients with pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which there is no standard therapy.
  2. Measurable disease at baseline.
  3. At least four weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agents, six weeks if the last regimen included BCNU or mitomycin C, six weeks if the agent was an antibody, four weeks if a chimeric antibody. For targeted therapies such as Gleevec®, Tarceva®, Nexavar®, Iressa®, or Sutent® at least five half-lives need to have elapsed since the last dose. Patients must be recovered from the adverse effects of prior therapy at the time of enrollment.
  4. Age >/=18 years, male or female patients.
  5. Women of child-bearing potential or men whose sexual partners are women of child-bearing potential must agree to use two methods of adequate contraception (i.e., hormonal and barrier method of birth control) prior to study entry, for the duration of the study, and for 30 days after the last dose of study medication.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  7. Patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcL; absolute neutrophil count >/=1,500/mcL; platelets >/= 100,000/mcL; total bilirubin </= 2.0 mg/dL; AST(SGOT)/ALT(SGPT) </= 2.5 x upper limit of normal; and creatinine </= 2.0 mg/dL
  8. Patients must have an existing patent and viable central venous catheter, or have such a line inserted within 28 days prior to initiation of study drug.
  9. Patients must be able to understand and willing to sign a written informed consent document and have the capacity to follow study instructions.

Exclusion Criteria:

  1. Uncontrolled concurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, life-threatening cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results. Patients with a history of myocardial infarction in the last three months are also excluded from the trial.
  2. Patients with known brain metastases that are symptomatic
  3. Patients with leukemias or myelodysplastic syndrome (MDS).
  4. Patients who have undergone bone marrow or stem cell transplantation within the last 5 years.
  5. A requirement, as judged by the Principal Investigator, for primary prophylaxis with colony stimulating factors based on an expectation by the investigator of a risk of febrile neutropenia of 20% or greater or clinical factors that predispose the patient to increased complications from prolonged neutropenia as discussed in the latest American Society of Clinical Oncology (ASCO) recommendations for the use of white blood cell growth factor guidelines.
  6. Nursing or pregnant women.
  7. Documented HIV, HBV or HCV infection.
  8. Patients with hypersensitivity to compounds of similar chemical or biologic composition to TTP607 or constituents of the intravenous (i.v.) formulation.
  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: NCT00939172

Sponsors and Collaborators
M.D. Anderson Cancer Center
TransTech Pharma
Investigators
Study Chair: Jennifer J. Wheler, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00939172     History of Changes
Other Study ID Numbers: 2007-0219
Study First Received: July 10, 2009
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Refractory Solid Malignancies
Solid tumor
Lymphoma
TTP607

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014