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Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information


Inclusion Criteria:



- Must be able to provide informed consent

- In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma
that has relapsed and is refractory to standard therapy, or for which no standard
therapy exists

- In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or
cytologically confirmed

- Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and
must not have received more than 2 prior chemotherapeutic regimens

- Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV
disease that is surgically incurable and unresectable

- Melanoma patients with documented BRAF mutation that is known to be responsive to
BRAF inhibitors must have failed or be intolerant to such inhibitors

- Must have measurable disease

- Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor
tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry

- Must by at least 18 years old

- Must have adequate organ function

Exclusion Criteria:

- Prior cancer therapies must have completed at least 14 days or 5 half-lives
(whichever is longer) prior to first dose of AMP-224

- Prior treatment with an anti-PD1 antibody therapy

- Known antibody response against prior antibody therapy or fusion protein therapeutics

- Major surgery within 4 weeks prior to first dose of AMP-224

- Prior allogeneic or autologous bone marrow or organ transplantation

- Known and/or a history or evidence of autoimmune disease except vitiligo, resolved
childhood asthma and stable hypothyroidism

- Received an immunomodulatory drug within 2 weeks of first dose of AMP-224

- Active infections requiring antibiotics, physician monitoring, or recurrent fevers
>100.4 degrees fahrenheit associated with a clinical diagnosis of active infection

- Patients with cirrhosis

- Clinically significant cardiac or electrocardiogram abnormalities

- History or evidence of HIV

- Active viral disease (except when the viral infection is associated with the
malignancy)

- Regular use of illicit drugs or a recent history of substance abuse

- Pregnant or breastfeeding women

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events.

Outcome Time Frame:

From start of study drug administration until the date of first documented progression or date of death from any cause; through Day 56 of final cycle.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AMP-224-01

NCT ID:

NCT01352884

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Cancer
  • Cancer
  • Carcinoma
  • Tumor
  • Solid tumor
  • Metastatic
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Karmanos Cancer InstituteDetroit, Michigan  48201
Carolina BioOncology InstituteHuntersville, North Carolina  28078
Sarah Cannon Research InstituteNashville, Tennessee  37203