TTP607 in Refractory Solid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939172
Recruitment Status : Withdrawn
First Posted : July 14, 2009
Last Update Posted : July 31, 2012
vTv Therapeutics
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Advanced Cancers Lymphoma Drug: TTP607 Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: End of each 15 day cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00939172

Sponsors and Collaborators
M.D. Anderson Cancer Center
vTv Therapeutics
Study Chair: Jennifer J. Wheler, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00939172     History of Changes
Other Study ID Numbers: 2007-0219
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms: