Clinical trials: Phase I
Amenorrhea
Determination of the Lowest, Safe and Effective Dose of Proellex
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
- Trial name
- NCT01187043
- Testing
- Proellex
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Cervical Cancer, Cancer
A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
This was a multicenter, open-label, 2-part randomized study of MEDI4736 administered as monotherapy or in combination with ADXS11-001 to participants with recurrent/persistent or metastatic squamous or non-squamous carcinoma of…
- Conditions
- Cervical Cancer, Cancer, Head and Neck Cancer
- Trial name
- NCT02291055
- Testing
- ADXS11-001, MEDI4736
- Where
- 17 sites in United States
- Volunteers
- 75 people
- Sponsor
- Advaxis, Inc.
Brain Tumors, Metastatic Disease
Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors.
- Trial name
- NCT00369785
- Testing
- donepezil hydrochloride
- Where
- 16 sites in United States
- Volunteers
- 198 people
- Sponsor
- Wake Forest University Health Sciences
Colorectal Neoplasms, Lung Neoplasms
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
- Conditions
- Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms
- Trial name
- NCT00976508
- Testing
- figitumumab, pegvisomant
- Where
- 5 sites in United States, Canada and 2 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.
- Trial name
- NCT01285518
- Testing
- PF-05231023
- Where
- 5 sites in United States
- Volunteers
- 84 people
- Sponsor
- Pfizer
Prostate Cancer, Endometriosis
A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
- Trial name
- NCT02093390
- Testing
- TAK-385, Fluconazole, Atorvastatin
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Breast Neoplasms
MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer
This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.
- Trial name
- NCT01097460
- Testing
- MM-111 + Herceptin
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Merrimack Pharmaceuticals
Safety, Tolerability
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT02209506
- Testing
- MLN3126
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Takeda
Cervical Carcinoma, Endometrioid Adenocarcinoma
Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
This phase I trial studies the side effects and best dose of adavosertib when given together with external beam radiation therapy and cisplatin in treating patients with cervical, vaginal, or uterine cancer.
- Conditions
- Cervical Carcinoma, Endometrioid Adenocarcinoma, Malignant Female Reproductive System Neoplasm, Recurrent Cervical Carcinoma
- Trial name
- NCT03345784
- Testing
- Adavosertib, Cisplatin, External Beam Radiation Therapy
- Where
- 8 sites in United States, Canada
- Volunteers
- 10 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Colorectal Cancer
ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the…
- Trial name
- NCT01075048
- Testing
- Tivantinib, Cetuximab, Irinotecan
- Where
- 40 sites in United States, France and 3 more
- Volunteers
- 131 people
- Sponsor
- Daiichi Sankyo
Neurofibromatosis Type 1
Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints.
- Trial name
- SPRINKLE (NCT05309668)
- Testing
- Selumetinib granule formulation, Selumetinib capsule formulation
- Where
- 16 sites in United States, Germany and 5 more
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Solid Tumors
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
This study was to determine the maximum-tolerated dose (MTD) and/or the optimal biological dose (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC) administrations of RO7172508 as monotherapy, with or…
- Trial name
- NCT03539484
- Testing
- RO7172508, Obinutuzumab, Tocilizumab
- Where
- 6 sites in Belgium, Canada and 2 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
X-Linked Retinitis Pigmentosa
Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR)
Phase 1 of the study is a dose escalation of the subretinal administration of AAV5-hRKp.RPGR vector to assess the safety of this vector in participants with XLRP caused by mutations in RPGR.
- Trial name
- NCT03252847
- Testing
- AAV5-RPGR
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 49 people
- Sponsor
- MeiraGTx UK II Ltd
Basaloid Squamous Cell Carcinoma, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its…
- Conditions
- Basaloid Squamous Cell Carcinoma, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Oropharyngeal Squamous Cell Carcinoma
- Trial name
- NCT03952585
- Testing
- Biopsy Procedure, Biospecimen Collection, Cisplatin
- Where
- 494 sites in United States, Canada
- Volunteers
- 384 people
- Sponsor
- National Cancer Institute (NCI)
Lung Cancer
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
- Trial name
- NCT00843726
- Testing
- Arm 1 stereotactic body radiation therapy, Arm II stereotactic body radiation therapy
- Where
- 3 sites in United States
- Volunteers
- 98 people
- Sponsor
- Roswell Park Cancer Institute
Advanced Solid Tumor
Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose…
- Trial name
- MINOTAUR (NCT05147350)
- Testing
- RP-6306 (oral PKMYT1 inhibitor)
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 38 people
- Sponsor
- Debiopharm International SA
Oncology
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate)…
- Trial name
- NCT02521376
- Testing
- Entospletinib
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Multiple Myeloma and Plasma Cell Neoplasm
Studying T Cells in Blood and Bone Marrow Samples From Patients With Multiple Myeloma
RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about T cells and plan better treatment for multiple myeloma.
- Trial name
- NCT00897910
- Testing
- flow cytometry, immunoenzyme technique, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor, Microsatellite Stable (MSS) Colon Cancer
Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer
A phase I/II study of PI3Kinase inhibition (copanlisib) and anti-PD-1 antibody nivolumab in relapsed/refractory solid tumors with expansions in mismatch-repair proficient (MSS) colorectal cancer.
- Trial name
- NCT03711058
- Testing
- Copanlisib, Nivolumab
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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