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A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma

This study has been terminated.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00272415
First received: January 3, 2006
Last updated: March 9, 2009
Last verified: November 2007
  Purpose

This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.


Condition Intervention Phase
Melanoma
Drug: INO-1001
Drug: temozolomide
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV Melanoma

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ [ Time Frame: Length of study ]
  • Pharmacokinetic (PK) profile of intravenous INO-1001 [ Time Frame: Length of study ]
  • Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001 [ Time Frame: Length of study ]

Secondary Outcome Measures:
  • Safety of repeat dosing [ Time Frame: Length of study ]
  • Pharmacodynamic (PD) activity of intravenous INO-1001 [ Time Frame: Length of study ]
  • Response [ Time Frame: Length of study ]
  • Progression-free survival [ Time Frame: Length of study ]
  • Overall survival [ Time Frame: Length of study ]

Estimated Enrollment: 39
Study Start Date: October 2005
Arms Assigned Interventions
Experimental: 1 Drug: INO-1001
Intravenous repeating dose
Drug: temozolomide
Oral repeating dose

  Eligibility

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

Inclusion Criteria:

  • Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible
  • Measurable indicator metastases
  • Age 18 years or older
  • ECOG status 0-2
  • An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea
  • Hematocrit > 29%, ANC > 1500 cells/ul, platelets > 100,000 cells/ul
  • Serum creatinine within the laboratory's upper limit of normal
  • Serum AST and ALT ≤ 1.5 x the laboratory's upper limit of normal
  • Subject signed informed consent prior to subject entry

Exclusion Criteria:

  • Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen.
  • Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment.
  • Subjects previously treated with DTIC or TMZ
  • Symptomatic central nervous metastases
  • Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.
  • Confirmed diagnosis of hepatitis or HIV infection
  • Any medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial
  • Patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy
  • Patients unwilling to comply with the protocol or who in the judgment of the Principal Investigator are unable to abide by the rules of the protocol
  • Subjects who have received a potent CYP3A4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment
  • Subjects who have received amiodarone within 30 days of study drug administration
  • History of hypersensitivity reaction to more than three (3) drugs or to mannitol
  • Patients who have received any investigational study agent within 30 days of Day 1 of Cycle 1
  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: NCT00272415

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Jennifer Low, M.D., Ph.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00272415     History of Changes
Other Study ID Numbers: IPC-06-2004, INO4136g
Study First Received: January 3, 2006
Last Updated: March 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
INO4136g
inotek
Parp
Temodar

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014