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ProtocolTrial Name and Objective
051407

A continuation clinical trial of every three-week dosing of oral ONC201 in patients with advanced solid tumors

Primary Objectives
To evaluate the long-term safety and tolerability of ONC201 administered orally in patients with advanced cancers.

Secondary Objectives
1. To characterize pharmacokinetics of ONC201.

2. To assess serum biomarkers of therapeutic response to ONC201.

3. To assess preliminary antitumor activity of ONC201 as a single agent in advanced solid tumors
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081203

Autophagy inhibition to augment mTOR inhibition: A phase I/II trial of RAD001 and hydroxychloroquine in patients with previously treated renal cell carcinoma

Primary Objective Phase I
To determine the maximum tolerated dose of HCQ when administered with daily RAD001 in patients with advanced RCC.
Primary Objective Phase II

To estimate the rate of 6 month PFS in RCC patients receiving RAD001 and HCQ who have had between 1 and 3 prior treatment regimens for advanced disease.

Secondary Objectives
1) To estimate the response rate of this combination.
2) To measure evidence of autophagy inhibition by EM and LC3, p62 immunoblotting in PBMC and tumor tissue
3) To define significant associations between baseline composite p-p70S6K/pAKt score (14) and PFS or response. To characterize significant associations between baseline genetic mutations and outcome and associations between baseline expression of LC3, p62, ATG5 and Beclin and clinical outcome.
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051403

A first-in-human phase I single-agent open-label dose-escalation study of every three-week dosing of oral ONC201 in patients with advanced solid tumors

Dose escalation:
To determine the recommended maximal tolerated dose (MTD) or recommended phase II dose of single agent ONC201 orally once every three weeks

Dose expansion:
To characterize the safety and tolerability of ONC201 in patients with tumors that have a high frequency of PI3 kinase pathway or RAS signaling activation (metastatic castrate resistant prostate cancer, metastatic renal cell carcinoma, melanoma, glioblastoma multiforme, breast cancer).
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081403

Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer

To determine the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed clinical TxN1Mx or TxNxM1 prostate cancer (herein, collectively referred to as metastatic prostate cancer).

Time to PSA nadir and castration resistance following cytoreductive prostatectomy and
subsequent standard systemic therapy, androgen deprivation.
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051404

NCI/CTEP #8808: An Early Phase I Study of ABT-888 in Combination with Carboplatin and Paclitaxel in Patients with Hepatic or Renal Dysfunction and Solid Tumors

Primary Objectives: (1) to determine the pharmacokinetics and pharmacodynamics of ABT-888 in patients with varying degrees of renal or hepatic dysfunction. (2) to determine the maximum tolerated dose (MTD) of ABT-888 in combination with carboplatin and paclitaxel for patients with varying degrees of liver or kidney function. (3) to provide dosing recommendations for ABT-888 in combination with carboplatin and paclitaxel based on degree of hepatic and renal impairment.
Seconday Objectives: (1) to define the dose-limiting toxicity and other toxicities associated with the use of this combination in patients with varying degrees of renal or hepatic dysfunction. (2) to evaluate the pharmacokinetic parameters of ABT-888, carboplatin and paclitaxel when administered as a combination in patients with varying degrees of renal or hepatic dysfunction. (3) to evaluate the pharmacodynamic measurement of PAR and platinum adducts in tumor cells associated with the use of this combination in patients with varying degrees of renal or hepatic dysfunction.
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051405

A Phase I Study of the Clinical and Immunologic Effects of ALT-803, a Novel Recombinant IL-15 Complex, in Patients with Advanced Melanoma

Primary Objectives: (1) to study the safety of escalating doses of ALT-803 in patients with advanced melanoma and screen the selected dose in an expansion cohort for evidence of antitumor activity. (2) to evaluate the effect of escalating doses of ALT-803 on the peripheral blood white blood cell (WBC) and absolute lymphocyte (ALC) counts.
Secondary Objectives: To evaluate the effect of escalating doses of ALT-803 on: (1) the number and phenotype of peripheral blood mononuclear cells (PBMCs), including T and natrual killer (NK) cells by multiparameter flow cytometry. (2) the level of immune response to autochthonous viral and tumor antigens by interferon-gamma ELISPOT. (3) immunogenicity and pharmacokinetics of ALT-803. (4) overall objective response rate (ORR) and response duration.
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011408

MI-CP204: An Open-label, Phase 1/2 Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-cell Malignancies

2.1 Primary Objectives
The primary objectives of this study are listed by study arm.
Arm A
1. To determine the MTD or OBD of MEDI-551 in subjects with relapsed or refractory
advanced B-cell malignancies (CLL, including SLL, DLBCL, and FL)
2. To determine the preliminary safety profile of MEDI-551
Arm B
Dose escalation
1. To determine the MTD or highest protocol-defined dose of MEDI-551 in the absence of
exceeding the MTD in subjects with relapsed or rituximab-refractory CLL (defined as
those with less than a PR or progression within 6 months after completing therapy with
rituximab)
Dose expansion
1. To evaluate further the safety and tolerability of MEDI-551 at the dose selected in the
dose-escalation phase in subjects with relapsed or rituximab-refractory CLL
2. To evaluate the clinical activity of MEDI-551 at the dose selected in the dose-escalation
phase in subjects with relapsed or rituximab-refractory CLL
Arm C
Dose escalation
1. To determine the safety and tolerability of MEDI-551 in combination with rituximab at
the MTD or the highest protocol-defined dose in the absence of exceeding the MTD in
subjects with aggressive lymphomas
Dose expansion
1. To evaluate further the safety and tolerability of MEDI-551 at the dose selected in the
dose-escalation phase in subjects with aggressive lymphomas
2. To evaluate the clinical activity of MEDI-551 at the dose selected in the dose-escalation
phase in combination with rituximab in relapsed and rituximab-refractory population
(defined as those with less than a PR or progression within 6 months after completing
therapy with rituximab)
Arm D
1. To evaluate the clinical activity of MEDI-551 in subjects with any anti-CD20-refractory
aggressive lymphomas (defined as any subject with less than a PR to any prior
anti-CD20-based therapy or progression within 6 months after completing therapy with
any anti-CD20-based regimen, including maintenance rituximab)
The secondary objectives of this study are listed by study arm.
Arm A
1. To determine the preliminary efficacy profile of MEDI-551 in subjects with advanced Bcell
malignancies (CLL [including SLL], DLBCL, and FL)
2. To determine the PK of MEDI-551 in subjects with advanced B-cell malignancies
3. To determine the effect of treatment with MEDI-551 on circulating lymphocyte
populations and Ig levels, including time to recovery after treatment
4. To determine the IM of MEDI-551 in subjects with advanced B-cell malignancies
Arm B
1. To evaluate the PK and IM of MEDI-551 at doses studied in subjects with relapsed or
rituximab-refractory CLL
2. To evaluate the effect of therapy on the B-lymphocyte level in peripheral blood,
including time to recovery of B-lymphocyte level
Arm C
1. To evaluate the PK and IM of MEDI-551 when administered in combination with
rituximab in subjects with aggressive lymphomas
2. To evaluate the effect of therapy on the B-lymphocyte level in peripheral blood,
including time to recovery of B-lymphocyte level
Arm D
1. To determine the safety and tolerability of MEDI-551 in subjects with any anti-CD20-
refractory aggressive lymphomas
2. To evaluate the PK and IM of MEDI-551
3. To evaluate the effect of therapy on the B-lymphocyte level in peripheral blood,
including time to recovery of B-lymphocyte level
Exploratory Objectives
Arm A
1. To evaluate potential predictive and pharmacodynamic biomarkers and their association
with response to MEDI-551 in subjects with advanced B-cell malignancies
Arm B
1. To evaluate potential predictive and pharmacodynamic biomarkers and their association
with response to MEDI-551 in subjects with relapsed or rituximab-refractory CLL
2. To evaluate degree of saturation of CLL B-cell sink based on MEDI-551 concentration
levels
3. To evaluate the ability of treatment to eliminate minimal residual disease (MRD)
Similar objectives for Arms C and D.
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051406

NCI/CTEP #9571: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinic) and Cyclosporin A (CsA) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Colorectal Cancer

Primary Objective: To determine the maximum tolerated dose (MTD)and dose-limiting toxicities (DLT) of the combination of AZD6244 and cyclosporin A in adult patients with advanced solid tumors.
Seconday Objectives: (1) To determine the safety profile and tolerability of thsi regimen in this patient population. (2) To determine the pharmacokinetics of the combination. (3) To evaluate the selected biomarkers of drug effect in patients with advanced solid tumors or metastatic CRC. (4) Evaluate the activity of the combination in terms of objective response rate (per RECIST 1.1), overall survival, and progression-free survival.
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011411

R1979-HM-1333: An Open-label, Multi-center Phase I Study to Investigate the Safety and Tolerability of REGN1979, an anti-CD20 x anti-CD3 bispecific monoclonal antibody, in Patients with CD20+ B-cell Malignancies previously treated with CD20 directed antibody therapy.

The primary objective of the study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) of REGN1979 administered intravenously (IV).

The secondary objectives of the study are:
* To characterize the pharmacokinetic (PK) profile of REGN1979
* To assess the immunogenicity of REGN1979
* To study the preliminary antitumor activity of REGN1979 administered to patients with CD20+ B-cell malignancies (non-Hodgkin's lymphoma [NHL] and chronic lymphocytic leukemia [CLL]) previously treated with anti-CD20 antibody therapy.
o Minimal residual disease (MRD) assessments in patients with CLL

The exploratory objectives of the study are:
* To evaluate biomarkers that may correlate with mechanism of action, observed toxicity, and potential anti-tumor activity including, but not limited, to:
o Cytokine profiling
o Peripheral blood B-cell and T-cell subsets and immune phenotyping
o Changes in gene expression in peripheral blood
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051105

NCI/CTEP #8983: A Phase I Trial of MK-2206 and Hydroxychloroquine in Solid Tumors, Melanoma, Renal and Prostate Cancer to Examine the Role of Autophagy in Tumorigenesis

Primary - to define the maximum tolerated dose (MTD) of MK-2206 and hydroxychloroquine (HCQ) when used in combination.
Secondary - (1) to determine the side effects and activity of MK-2206 and hydroxychloroquine when used in combination. (2) to determine if hydroychloroquine alters the pharmcokinetics of MK-2206 due to a drug-drug interaction. (3) to validate biomarkers for autophagy detection
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101201

A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38 MAPK Inhibitor, plus Gemcitabine and Carboplatin versus Gemcitabine and Carboplatin for Women with Platinum-Sensitive Ovarian Cancer

The primary objective of the Phase 1b portion of this study is to determine the recommended Phase 2 dose of LY2228820 that can be safely administered in combination with gemcitabine and carboplatin.
The primary objective of the Phase 2 portion of this study is to compare the progression-free survival in patients treated with LY2228820 plus gemcitabine and carboplatin versus placebo plus gemcitabine and carboplatin.

The secondary objectives of the study are to evaluate:
1. Change in tumor size, CA125 (serum biomarker for ovarian cancer), overall response rate, and overall survival (OS)
2. Safety and tolerability of the combination: LY2228820 plus gemcitabine and carboplatin
3. Pharmacokinetics (PK) of LY2228820 and evaluation for effect of LY2228820 on the PK of gemcitabine, its metabolite (dFdU), and carboplatin
4. Biomarkers related to p38 MAPK pathway activity and the pathogenesis of ovarian cancer
5. Patient-reported outcomes for patients enrolled in the Phase 2 portion of the study
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011201

CC-122-ST-001: A Phase IA/IB, Multi-center,Open-Label, Dose Finding Study To Assess The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotrophic Pathway modifier CC-122 administered orally to subjects with advanced solid tumors, NHL and Multiple Myeloma.

Primary Objectives:
1. To determine the safety and tolerability of CC-122 given orally and to define the non-tolerable dose, MDT and the recommended phase 2 dose.
2. To determine the PK and extent of urinary excretion of CC-122.
Secondary Objectives:
1. Preliminary assessment of the anti-tumor activity of CC-122.
2. To determine the CNS penetration of CC-122.
3. To evaluate the PD effects of CC-122 on gene expression, cytoskeletal structure and cell surface organization in peripheral blood cell components.
4. To evaluate modulation of circulating cytokines in the plasma.
5. To evaluate modulation of immune effector cells and their subtypes in peripheral blood.
6. To evaluate the modulation of cytokine production in ex vivo LPS and anti-CD3 stimulated peripheral blood.
7. To determine the plasmacogenomic relationship between tumor gene sequence or copy number and response.
8. To explore the relationship between PK and PD effects of CC-122.
9. To explore the effect of CC-122 on biomarkers of angiogenesis in pre-and during treatment tumor biopsies when available.
10. To characterize the principle metabolites of CC-122 in plasma and urine.
11.To determine the PK of CC-122 anantiomers in urine and plasma.
12. To assess relationship between renal function and the PK of CC-122.
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051206

ECOG E2511 Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib(ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer

This is a 2-part study consisting of a lead-in phase I dose escalation trial to establish the safety and
determine the optimal dose of veliparib (ABT-888) that will be safely combined with standard doses
of cisplatin and etoposide (CE). This will be followed by a randomized double blind phase II clinical
study to compare CE plus placebo against CE plus veliparib in patients with previously untreated
SCLC.
2.1 Phase I Primary Endpoints
To determine the recommended phase II dose (RP2D) of veliparib to use in combination with
CE.
2.2 Phase II Primary Endpoints
To determine whether the addition of ABT-888 to cisplatin etoposide (CE) results in
improved progression free survival (PFS) over CE with placebo in the frontline therapy of
newly diagnosed extensive stage small cell lung cancer
2.3 Phase II Secondary Endpoints
2.3.1 To determine the overall survival (OS) associated with the combination of CE plus
ABT-888
2.3.2 To assess the overall response rate (ORR) as well as complete response rate
(CRR) associated with the combination of CE plus ABT-888
2.3.3 To determine the toxicity profile of the combination of ABT-888 and CE
chemotherapy in this patient population.
2.3.4 To conduct exploratory correlative analysis of the impact of select biomarkers.
2.3.5 To compare the overall toxicity profile and specifically the incidence and severity of
chemotherapy-induced peripheral neuropathy with the addition of ABT-888 to CE
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071303

PCRT 12-001: A Phase IB/II Pilot Trial of NAB-Paclitaxel Plus Cisplatin Plus Gemcitabine (NABPLAGEMl) in Patients with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

1.The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic PDA.
2.Evaluate the safety of cisplatin plus nab-paclitaxel plus gemcitabine
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051302

JNJ-42756493: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

1) To determine a safe and biologically active Phase 2 dose (recommended Phase 2 dose [RP2D]) for JNJ-42756493 (Part 1 Dose Escalation)
2) To evaluate the feasibility of treating a molecularly-defined subset of subjects with squamous celllung cancer and subjects with breast cancer with JNJ-42756493 at the RP2D (Part 2 Dose Expansion)
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091311

A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma

Phase 1b: To determine the safety and tolerability of talimogene laherparepvec in combination with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.
Phase 2: To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone as assessed by overall survival (OS) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.
Secondary Objective(s):
Phase 1b:
To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab as
determined by objective response rate (ORR)
To assess the safety of talimogene laherparepvec in combination with ipilimumab as determined by incidence of all adverse event (AE)s, grade ? 3 AEs (AEs), serious adverse events (SAEs), and events requiring the discontinuation of study drug, local effects on the tumor (ie, pain, inflammation and ulceration), clinically significant laboratory changes, and clinically significant changes in vital signs not defined as DLT
Phase 2:
To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab versus
ipilimumab alone as determined by ORR, duration of response (DOR), time to response (TTR), progression free survival (PFS), resection rate, 1-year survival rate, and 2-year survival rate
To assess the safety of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone as determined by incidence of all AEs, grade ? 3 AEs, SAEs, and events requiring the discontinuation of study drug, local effects on the tumor (ie, pain, inflammation and ulceration), clinically significant laboratory changes, and clinically significant changes in vital signs
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071306

DEK-DKK1-P102: A Two Part, Phase 1, Multi-center, Open-label Study of DKN-01 in Combination with Weekly Paclitaxel; Arm A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Arm B: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors

Primary Objective
The primary objective of this study is to characterize the safety and tolerability of DKN-01 in combination with weekly paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer.

Secondary Objectives
The secondary objectives of this study are:
h To estimate the overall response rate (ORR) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To estimate progression free survival (PFS), duration of response (DoR), and overall survival (OS) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To characterize the pharmacokinetics of DKN-01 in combination with paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer
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051306

A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.

To assess the safety and tolerability of MSB0010718C and to determine the maximum tolerated dose (MTD) of MSB0010718C in subjects with metastatic or locally advanced solid tumors.
Secondary objectives
- To characterize the pharmacokinetic (PK) profile of MSB0010718C and to correlate exposure with target occupancy.
- To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure
and biological activity.
- To assess the best overall response (BOR) andprogression-free survival time (PFS) according to Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1.
- To assess the immune-related BOR (irBOR) and immune-related PFS (irPFS) using the modified Immune-Related Response Criteria (irRC),
derived from RECIST 1.1.
- To assess overall survival time (OS).
- To evaluate biological responses to MSB0010718C in blood/serum.
- To evaluate the association between tumor programmed death ligand 1 (PD-L1) expression and BOR.
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