Metastatic MelanomaPhase 2NCT00627419
A Study Evaluating the Safety and Antitumor Activity of IPI-504, in Patients With Metastatic Melanoma
A Phase 2 study testing IPI-504 in people with Metastatic Melanoma, run by Infinity Pharmaceuticals, Inc. at 17 sites in United States.
Trial summary
To evaluate the antitumor activity of IPI-504 in patients with metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- IPI-504
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 17 sitesUnited States
- Study dates
- Feb 2008to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Colorado Health Sciences Center
Aurora, Colorado, 80010
Dana-Farber Cancer Institute
Boston, Massachusetts, 02021
Gabrail Cancer Center
Canton, Ohio, 44718
Univ. of TX, MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Univ. Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
Columbia University
New York, New York, 10032
Univ. of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
Mayo Comprehensive Cancer Center
Rochester, Minnesota, 55905
Sharp Memorial Hospital
San Diego, California, 92123
Washington School of Medicine
St Louis, Missouri, 63110
Arizona Cancer Center
Tuscon, Arizona, 85724
About this study
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
To evaluate the antitumor activity of IPI-504 in patients with metastatic melanoma.
Read the 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.
- Conditions
- Metastatic Melanoma
- Being tested
- IPI-504
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-504Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IPI-504 Receives: Drug: IPI-504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the first administration of IPI-504 through 30 days after the last dose of IPI-504
Secondary outcomes (1)
Evaluating other antitumor activities, safety, and PK parameters of IPI-504 in this patient population.
Measured: from the first administration of IPI-504 through 30 days after the last dose of IPI-504 (confirm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Study closed \& recruitment will not recommence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Santabarbara, M.D., Study director, Infinity Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627419
- Sponsor's protocol ID
- MI-CP159
- Status last verified
- Dec 2012
- First submitted
- 21 Feb 2008
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00627419
- Acronym / sponsor ID
- MI-CP159
- Conditions
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed \& recruitment will not recommence
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the antitumor activity of IPI-504 in patients with metastatic melanoma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IPI-504IPI-504 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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);
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPI-504Dose 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. | Drug | 1 |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study was stopped early (reason given: Study closed \& recruitment will not recommence). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Santabarbara, M.D. study director
Infinity Pharmaceuticals, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI-504 in people with Metastatic Melanoma, run by Infinity Pharmaceuticals, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study closed \& recruitment will not recommence). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.