Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Proton Therapy

IMRT

Neha Vapiwala, MD

This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.

This study will be done in two phases, first, a feasibility study and then a registration study. In the first, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Mild Hypofractionation With Proton Therapy or Intensity Modulated Radiation Therapy (IMRT) for Intermediate-Risk Prostate Cancer

A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate -Risk Adenocarcinoma of the Prostate

Unable to tolerate 10% of treatments using proton radiotherapy. Unable to complete all treatments. Cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.

Any grade 2 or higher GI or GU toxicity, other than GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU. In the feasibility phase of this trial, the observation window for acute toxicty is extended to 60 days from completion of radiotherapy, as a feasibility precaution.

Any grade 2 or higher GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU which occurs beyond 60 days from completion of radiotherapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.

The time from start of radiotherapy to either documented increase in PSA or clinical progression of disease (based on CT, MRI, or bone scan), death due to any cause or last patient contact alive.

Abramson Cancer Center at Penn Medicine

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Drug: Docetaxel - administered intravenously

Drug: vantictumab - administered intravenously

Vantictumab will be administered intravenously

vantictumab

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.

Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with docetaxel. Up to approximately 34 patients may be enrolled into the study.

A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC

A Phase 1b Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer

Apparent half life, AUC, clearance, volume of distribution

OncoMed Pharmaceuticals, Inc.

Gland and Hormone Related Diseases

Rare Diseases

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Adenocarcinoma, Follicular

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

Thyroid Cancer, Follicular

Micronutrients

Anti-Infective Agents

Sunitinib

Iodine

Cadexomer iodine

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.

SU011248, Sutent

Kenneth D Burman, MD

This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed.

This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately two years after completing standard therapy. During this time, study participants will be followed closely by their doctor.

This is a two-stage, phase II, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.

Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Overall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.

Pfizer

Medstar Health Research Institute

Sutent 37.5 mg/day will be given orally.

SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.

Treatment Arm - Sutent

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr Kenneth D. Burman

Progression Free Survival

Overall Survival

Overall Study

OMP-59R5

David C. Smith, MD

Anthony W. Tolcher, MD

This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.

Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-59R5 every week until disease progression.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in \<2 of the 6 subjects experiencing a DLT.

A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors

A Phase 1 Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors

The number of patients experiencing Adverse Events will be reported.

The half-life, volume of distribution, and clearance will be determined

The rate of neutralizing antibodies will be determined

The response outcome in patient will be determined

dose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks

OMP-54F28

This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid tumor for which there is no remaining standard curative therapy. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.

Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days following the discontinuation of OMP-54F28.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses between the dose levels listed above) may also be tested upon agreement with the investigators and the study sponsor. In addition, alternate dosing schedule cohorts of OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the investigators and the study sponsor. These alternative less frequent dosing schedules may be evaluated if emerging data suggest that once every 3 week dosing results in tolerability concerns. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from Days 0-28. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects who have a \>2-fold increase of their fasting β-CTX or a decline of \>3% in their bone mineral density (BMD) from screening or a T-score decline to \<-2.5 in the total femur or L1-L4 DEXA scan measurement will be started on zoledronic acid. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive OMP-54F28 until disease progression. An additional 6 subjects will be enrolled in an expansion cohort at the highest dose level that results in \<2 of the 6 subjects experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours) or Grade 4 adverse event (DLT). Tumors of particular interest for inclusion in the expansion cohort include sarcomas, basal cell carcinoma, ovarian cancer, desmoid tumors and prostate cancer given the known importance of the Wnt pathway in these malignancies.

A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors

A Phase 1 Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors

The pharmacokinetic (PK) parameters to be assessed are study drug half-life (t½), volume of distribution (Vd), and clearance (CL).

The response outcome in patients will be determined.

Bayer

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Carboplatin

Every patient will receive eribulin and carboplatin. Each cycle is 21 days (or 3 weeks). Eribulin and carboplatin will be given intravenously on days 1 and 8 of each cycle.

Eribulin will be administered on days 1 and 8 slow IV push over 2 to 5 minutes. Premedications will be given per institutional guidelines.

Level 1: 0.9 mg/m\^2; Level 2: 1.1 mg/m\^2; Level 3: 1.4 mg/m\^2

Eribulin

Carboplatin will be administered intravenously on day 1 and day 8 of each cycle, immediately following eribulin infusion at a dose of area-under-the-curve (AUC) 2 over 30 minutes in 250 ML of 0.9 % normal saline. Carboplatin dose will be calculated using the Calvert formula using AUC of 2 as follows: Carboplatin dose (mg) = 2 X (GFR + 25).

Heather Han, M.D.

This study is being done to see how safe the combination of eribulin and carboplatin is and if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which control every function in the body. Some cells stop working like they should and become cancer cells. These cancer cells grow and multiply rapidly and can cause destruction to normal body organs. Eribulin and carboplatin have both been approved by United States Food and Drug Administration (FDA) for use in the treatment of breast cancer. The combination of these two drugs and the safest dose of eribulin to use is experimental.

A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients

A Phase I Dose Escalation Study of Eribulin in Combination With Weekly Carboplatin for the Treatment of Metastatic Breast Cancer

The primary objective of the trial is to determine the safety and tolerability of eribulin mesylate and carboplatin in combination. The primary safety endpoint is dose limiting toxicity (DLT). The MTD is defined as the dose at which the percentage of patients experiencing a DLT is the closest to 30%. Planned doses for evaluation of eribulin mesylate include 0.9, 1.1, and 1.4 mg/m\^2.

Response rate will be provided for the subjects in the study overall. Response rates and 95% confidence intervals will be provided. Eribulin mesylate pharmacokinetic variables: peak concentration (CPeak) and trough plasma concentrations (Ctrough) will be calculated as appropriate and summary statistics will be provided.

Eisai Inc.

H. Lee Moffitt Cancer Center and Research Institute

IV infusion. Subjects with stable disease or a response at Day 56 will be allowed to continue until disease progression.

OMP-18R5

This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.

Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-18R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-18R5 every week until disease progression.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-18R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in \< 2 of the 6 subjects experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours) or 4 adverse event (DLT).

A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors

A Phase 1 Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors

The half-life, volume of distribution, and clearance will be determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mild Hypofractionation With Proton Therapy or Intensity Modulated Radiation Therapy (IMRT) for Intermediate-Risk Prostate Cancer	NCT01352429	Prostate Adenoc...	Proton Therapy IMRT	18 Years -	Abramson Cancer Center at Penn Medicine
A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC	NCT01957007	Solid Tumors	Docetaxel vantictumab	18 Years - 90 Years	Mereo BioPharma
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer	NCT00668811	Papillary Thyro... Follicular Thyr... Differentiated ...	SU011248, Suten...	18 Years -	Medstar Health Research Institute
A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors	NCT01277146	Solid Tumors	OMP-59R5	18 Years - 90 Years	Mereo BioPharma
A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors	NCT01608867	Solid Tumors	OMP-54F28	18 Years - 90 Years	Mereo BioPharma
A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients	NCT01795586	Breast Cancer	Eribulin Carboplatin	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors	NCT01345201	Solid Tumors	OMP-18R5	18 Years - 90 Years	Mereo BioPharma
Mild Hypofractionation With Proton Therapy or Intensity Modulated Radiation Therapy (IMRT) for Intermediate-Risk Prostate Cancer	NCT01352429	Prostate Adenoc...	Proton Therapy IMRT	18 Years -	Abramson Cancer Center at Penn Medicine
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors	NCT01345201	Solid Tumors	OMP-18R5	18 Years - 90 Years	Mereo BioPharma
A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients	NCT01795586	Breast Cancer	Eribulin Carboplatin	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors	NCT01345201	Solid Tumors	OMP-18R5	18 Years - 90 Years	Mereo BioPharma

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