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An Open-Label, Multicenter, Phase I Dose-Escalation Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors


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

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Trial Information

An Open-Label, Multicenter, Phase I Dose-Escalation Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Life expectancy >/= 12 weeks

- ECOG performance status of 0 or 1

- Histologic or cytologic documentation of locally advanced, or metastatic solid
malignancy that has relapsed after or failed to respond to at least one prior regimen
or for which there is no standard therapy

- Evaluable or measurable disease. Prostate cancer patients with non-measurable disease
are eligible if they have two rising prostate-specific antigen (PSA) levels (5 ng/mL
measured 2 weeks apart) that meet the PSA Working Group criteria for progression
prior to initiation of study treatment. Ovarian cancer patients with non-measurable
disease are eligible if they have two rising CA-125 levels greater than the ULN (2
weeks apart prior to initiation of study treatment).

- Adequate hematologic and end organ function

- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement (by patient and/or partner) to use an effective
form of contraception and to continue its use until 90 days after the last dose of
study treatment

- Consent to provide archival tissue

Exclusion Criteria:

- Prior use of any monoclonal antibody within 4 weeks before Cycle 1, Day 1

- Experimental therapy within 4 weeks prior to Cycle 1, Day 1

- Palliative radiotherapy within 2 weeks prior to Cycle 1, Day 1

- Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1

- Major surgical procedure or trauma within 4 weeks prior to Cycle 1, Day 1. All wounds
must be fully healed on Cycle 1, Day 1.

- Evidence of significant, uncontrolled concomitant diseases which could affect
compliance with the protocol or interpretation of results, including significant
cardiovascular disease or pulmonary disease

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at screening or any major episode of
infection requiring treatment with IV antibiotics or hospitalization (relating to the
completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1

- History of other malignancy which could affect compliance with the protocol or
interpretation of results. Patients with a history of curatively treated basal or
squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed.
Patients with a malignancy that has been treated with curative intent will also be
allowed if the malignancy has been in remission without treatment for >/= years prior
to Cycle 1, Day 1.

- Presence of positive test results for Hepatitis B (Hepatitis B surface antigen
[HBsAg] and/or total HB core antibody [anti-HB-c]) or Hepatitis C (Hepatitis C virus
[HCV] antibody serology testing). Patients positive for anti-HB-c are eligible only
if PCR is negative for HBV DNA.

- Known history of HIV seropositive status

- Primary CNS malignancy, or untreated/active CNS metastases

- Pregnancy, lactation or breastfeeding

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0

Outcome Time Frame:

Days 1-28 of Cycle 1

Safety Issue:

No

Principal Investigator

Isabelle A. Rooney, M.B., Ch.B.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MFG4991g

NCT ID:

NCT01363024

Start Date:

August 2011

Completion Date:

April 2013

Related Keywords:

  • Solid Tumour
  • Solid Cancers
  • Neoplasms

Name

Location

Hinsdale, Illinois  60521
Phoenix, Arizona  85012
Fountain Valley, California  92708
Nashville, Tennessee  37203-1632
Denver, Colorado