Know Cancer

forgot password

A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901

Phase 1
18 Years
Open (Enrolling)
Ovarian Cancer, Merkel Cell Carcinoma, SCLC

Thank you

Trial Information

A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901



- Determine the safety and tolerability of BB-10901

- Determine the maximum tolerated dose of this drug in these patients.


- Determine the pharmacokinetics of this drug in these patients.

- Determine the efficacy of this drug in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.* Treatment repeats
every 21 days

NOTE: *Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive
infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the
independent Safety Review Board.

Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6
patients experience dose-limiting toxicity in course 1. Up to 40 patients are treated at the

After completion of study treatment, patients are followed for short term and long term
follow up and survival.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.

Inclusion Criteria


- Histologically or cytologically confirmed diagnosis of 1 of the following:

- Small cell lung cancer (SCLC)

- Other pulmonary tumors of neuroendocrine origin, including neuroendocrine
carcinoma or non-SCLC with neuroendocrine features

- Non-pulmonary small cell carcinoma

- Metastatic carcinoid tumor

- Other CD56-positive solid tumor

- Diagnoses other than SCLC must have confirmation of tumor CD56 expression before
study entry

- Relapsed or refractory disease

- Must have received at least 1 but no more than 3 prior chemotherapy regimens* and
recovered from any acute toxicities

- No prior chemotherapy for carcinoid or neuroendocrine tumors


- Relapsed or refractory Small cell lung cancer (SCLC)

- Metastatic Merkel Cell carcinomas

- Ovarian carcinomas

At the MTD:

SCLC patients must have received one, but no more than 1 prior chemotherapy regimen Merkel
and Ovarian patients must have received at least one prior chemotherapy regimen. Ovarian
patients must have received at least one platinum-based regimen.

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan

- No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, labile
blood pressure)

- No active brain metastases; no evidence of active disease and no requirement for
anticonvulsant medications or steroids.


- Life expectancy ≥ 3 months

- ECOG performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Bilirubin ≤ 3 times ULN

- No rapidly rising liver function tests (LFTs)

- Pancreatic function, amylase and lipase within upper limit of normal.

- No significant residual neurological or cardiac toxicity ≥ grade 2 after prior

- No myocardial infarction within the past 6 months

- No unstable angina pectoris

- No uncontrolled congestive heart failure

- No uncontrolled arrhythmia

- No severe aortic stenosis

- No history of multiple sclerosis or other demyelinating disease

- No Eaton-Lambert syndrome (para-neoplastic syndrome)

- No history of hemorrhagic stroke

- No CNS injury with residual neurologic deficit

- No ischemic stroke within the past 6 months

- No history of pancreatitis

- No current active infection or history of recurrent infection with varicella-zoster
virus (shingles) or cytomegalovirus

- No other concurrent serious infection

- No chronic alcoholism

- No other concurrent illness or condition that would interfere with study outcome

- No other malignancy within the past 3 years except adequately treated basal cell
carcinoma of the skin or carcinoma in situ of the cervix

- No known recent biochemical or clinical evidence of pancreatitis or extensive
metastatic disease involving the pancreas


- See Disease Characteristics

- Total cumulative dosage of prior anthracycline treatment must not exceed threshold
for cardiotoxicity

- No known hypersensitivity to previous monoclonal antibody therapy

- More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy

- More than 4 weeks since prior and no other concurrent investigational agents

- At least 4 weeks since prior and no concurrent surgery

- No other concurrent antineoplastic treatment, including immunotherapy or steroid

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments

Outcome Time Frame:

these tests will be conducted at various timepoints during a patients participation in the trial

Safety Issue:


Principal Investigator

Paul C. Lorigan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Christie Hospital NHS Foundation Trust


United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

June 2013

Related Keywords:

  • Ovarian Cancer
  • Merkel Cell Carcinoma
  • SCLC
  • recurrent small cell lung cancer
  • merkel cell carcinoma
  • ovarian cancer
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Ovarian Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
University of California San Francisco San Francisco, California  941104206
Nevada Cancer Institute Las Vegas, Nevada  89135
Oklahoma University Tulsa, Oklahoma  74104
The Ohio State University Cancer Center and Research Institute Columbus, Ohio