A Study Evaluating the Safety and Antitumor Activity of IPI-504, in Patients With Metastatic Melanoma

This study has been terminated.
(Study closed & recruitment will not recommence)
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00627419
First received: February 21, 2008
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

To evaluate the antitumor activity of IPI-504 in patients with metastatic melanoma.


Condition Intervention Phase
Metastatic Melanoma
Drug: IPI-504
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Arm, Multicenter Study Evaluating the Safety and Antitumor Activity of IPI-504, A Novel Small Molecule Inhibitor of Heat Shock Protein 90 (HSP90), in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Evaluating the antitumor activity of IPI-504 in patients with metastatic melanoma. The primary assessment of antitumor activity is the 6-month progression-free rate. [ Time Frame: from the first administration of IPI-504 through 30 days after the last dose of IPI-504 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluating other antitumor activities, safety, and PK parameters of IPI-504 in this patient population. [ Time Frame: from the first administration of IPI-504 through 30 days after the last dose of IPI-504 (confirm) ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IPI-504
Drug: IPI-504
Dose as a 30 to 60 minute IV infusion as part of a 21-day treatment cycle until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for patient withdrawal. IPI-504 will be administered twice weekly on Study Days 1, 4, 8, and 11 of each 21-day cycle.

Detailed Description:

To evaluate the antitumor activity of IPI-504 in patients with metastatic melanoma and to assessment of antitumor activity is the 6-month progression-free rate.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed, unresectable, Stage IV or recurrent melanoma, including mucosal melanoma (based on American Joint Committee on Cancer [AJCC] staging [Balch, 2001], see Appendix A).
  • Prior therapy with chemotherapy and/or immunotherapy for melanoma is allowed provided that therapy ended prior to study entry and all treatment-related toxicities have resolved to NCI CTCAE Grade ≤ 1 or patient's baseline;
  • Measurable disease (based on RECIST [Therasse, 2000]) defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan;
  • Have melanoma that can be biopsied once prior to treatment (all patients), and a second time during treatment with IPI504 (stage 2 patients);
  • Willingness for tumor biopsy at screening (all patients) and once during treatment (stage 2 patients only);
  • Males and females of at least 18 years of age at the time of study entry;
  • Female patients must be of non child-bearing potential (defined as being >1 year post-menopausal) or using effective contraception, eg, use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of IPI-504. Male patients must be surgically sterile or use a double-barrier method of contraception (condom with spermicide) from the time of the initiation of IPI-504 through 30 days after the last dose of IPI-504;
  • Eastern Cooperative Oncology Group performance status of 0 to 2;
  • Life expectancy of at least 16 weeks;
  • White blood cell (WBC) count ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3; Prothrombin time or international normalized ratio within normal range (unless a patient is receiving anticoagulation therapy), or PTT within normal range;
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (by Cockroft-Gault method);
  • Total bilirubin ≤ 1.5 × ULN [unless due to Gilbert's syndrome (unconjugated hyperbilirubinemia) in which case the total bilirubin should be ≤ 3.5 mg/dL], AST and ALT ≤ 2.5 × ULN, hepatic alkaline phosphatase ≤ 2.5× ULN;
  • LDH ≤ 1.5 × ULN;
  • Patients who have had prior radiation therapy are eligible provided that therapy was palliative in nature, not in the area where the tumor will be biopsied, at least one measurable lesion outside the radiation field, and all radiation-related toxicities have resolved to NCI CTCAE Grade ≤ 1 or patient's baseline;
  • Patients who had recovered from prior major surgery are eligible if all surgical wounds have healed;
  • Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.

Exclusion Criteria:

  • Received an investigational agent or therapy with any other kinase inhibitor within 2 weeks prior to study entry or any other antitumor therapy, such as cytostatic and/or cytotoxic drugs, hormonal therapy, radiation therapy, immunotherapy, or any biological response modifiers within 4 weeks prior to study entry;
  • Previous treatment with 17-AAG, 17-dimethylaminoethylamino-17-demethoxygel-danamycin (17-DMAG), or other known Hsp90 inhibitor;
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer;
  • Current or planned participation (from the day of study entry through 30 days after the last dose of IPI-504) in a research protocol in which an investigational agent or therapy may be administered;
  • Initiation or discontinuation of concurrent medication that alters CYP3A activity (see Appendix C) within 2 weeks prior to treatment with IPI-504. Patients who are on a stable dose of drugs known to alter CYP3A activity for > 2 weeks are eligible to enroll;
  • Presence of active infection or systemic use of antimicrobials within 72 hours prior to treatment with IPI-504;
  • Known brain metastases or primary brain tumors. Patients with ≤ 2 lesions are eligible provided:

    • Treated with surgery or stereotactic radiosurgery
    • The lesions are < 3 cm in size and have been stable for 2 months (by CT/MRI)
    • The patient has been off steroids for at least 1 week prior to dosing and:
    • The patient is allowed to have had whole brain radiation if performed in conjunction with surgery/stereotactic radiotherapy and the last dose of radiation occurred at least 2 months prior to dosing with IPI504.
  • Significant comorbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study (eg, cardiac disease such as acute coronary syndrome or unstable angina within 6 months, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident, or other conditions);
  • History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen values within normal limits since TURP, or superficial bladder cancer;
  • Women who are pregnant or lactating;
  • Sinus bradycardia (resting heart rate < 50 beats/min) secondary to intrinsic conduction system disease; Patients with sinus bradycardia secondary to pharmacologic treatment may enroll if withdrawal of the treatment results in normalization of the resting heart rate to within normal limits;
  • Screening QTc > 450 msec in males; QTc > 470 msec in females, or previous history of QTc prolongation while taking other medications; or
  • Active or recent history (within 3 months) of keratitis or keratoconjunctivitis, confirmed by ophthalmology or optometry exam.
  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: NCT00627419

Locations
United States, Arizona
Arizona Cancer Center
Tuscon, Arizona, United States, 85724
United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Florida
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana Univ. Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02021
United States, Minnesota
Mayo Comprehensive Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Pennsylvania
Univ. of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Univ. of TX, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Study Director: Pedro Santabarbara, M.D. Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00627419     History of Changes
Other Study ID Numbers: MI-CP159
Study First Received: February 21, 2008
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 28, 2014