Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Breast Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Breast Diseases

Skin Diseases

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Dose Level 0 (DL0): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200mg PO BID on days 1-28 and onalespib 20 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level 1 (DL1): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200mg PO BID on days 1-28 and onalespib 40 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level 2 (DL2): Patients received olaparib 300 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 300 mg PO BID on days 1-28 and onalespib 40 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level 3 (DL3): Patients received olaparib 300 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 300 mg PO BID on days 1-28 and onalespib 80 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level 2a (DL2a): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200 mg PO BID on days 1-28 and onalespib 80 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level 3a (DL3a): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200 mg PO BID on days 1-28 and onalespib 120 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Onalespib

Panagiotis A Konstantinopoulos

This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back (recurrent). Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVE:

I. To establish the maximum tolerated dose (MTDs) of olaparib and onalespib (AT13387) administered in combination in patients with advanced solid tumors.

SECONDARY OBJECTIVES:

I. To identify the dose-limiting toxicity (DLT) and other toxicities associated with olaparib and AT13387 administered in combination as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

II. To determine the recommended phase 2 doses (RP2D) of the combination of olaparib and AT13387.

III. To determine the plasma pharmacokinetics of olaparib and AT13387. IV. To document anti-tumor activity of the combination of olaparib and AT13387 as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression free survival (PFS). Although the clinical benefit of \[this/these\] drug(s) has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.

OUTLINE: This is a dose-escalation study.

Patients receive olaparib orally (PO) twice daily (BID) on days 1-7 (cycle 0). Beginning in cycle 1, patients receive olaparib PO BID on days 1-28 and onalespib intravenously (IV) over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and every 3 months for up to 2 years.

Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer

A Phase 1 Study of PARP Inhibitor Olaparib and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors With Expansion in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer

MTD was determined by testing increasing doses of the combination of olaparib PO and onalespib IV within dose escalation cohorts consisting of 3 to 6 evaluable participants. MTD reflects the highest dose combination that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLTs were defined based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Enrollment to this study was suspended prior to completion of the dose escalation due to discontinuation of further development of onalespib. A true single MTD therefore could not be determined. The two dose levels included in this outcome measure represent the highest well-tolerated dose combinations (Dose Level 2 \[DL2\]: Olaparib 300 mg PO BID and Onalespib 40 mg/m\^2 IV; and Dose Level 2a \[DL2a\]: Olaparib 200 mg PO BID and Onalespib 80 mg/m\^2 IV).

MTD was determined by testing increasing doses of the combination of olaparib PO and onalespib IV within dose escalation cohorts consisting of 3 to 6 evaluable participants. MTD reflects the highest dose combination that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLTs were defined based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

DLTs were based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 and were defined as any grade 3 or 4 non-hematologic toxicity (excluding grade 3: fatigue; diarrhea, constipation, and nausea and/or vomiting controlled with supportive measured within 24 hours; hypophosphatemia; hyponatremia; hypomagnesemia; and rash that resolves to \< grade 3 within \< 5 days), grade 4 neutropenia of \> 7 day duration, febrile neutropenia, grade 4 thrombocytopenia or bleeding associated with grade 3 thrombocytopenia, requirement for repeated blood transfusion within 4-6 weeks, any other grade 4 hematologic toxicity, any study treatment-related death, any grade 3 or 4 event considered to be dose-limiting in the opinion of the investigator, and the inability to take 75% or more of the planned dose for olaparib and 4 out of 6 doses for onalespib within the DLT period due to treatment-related adverse events.

Treatment-related toxicities in this outcome include non-hematologic and hematologic adverse events that were either Grade 3+ or occurred in at least 10% of all treated participants, and were considered at least possibly related to olaparib and/or onalespib. Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.

Responses determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI, where Objective Response (OR) represents either a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters).

Responses determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI, where Progressive Disease (PD) represents (relative to baseline) at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The duration of progression-free status was defined as the interval from the date of enrollment to date of either PD or date of last disease assessment.

National Cancer Institute (NCI)

One patient was enrolled under Dose Level 3, but was erroneously treated at Dose Level 2. This patient was replaced within the dose escalation, but remained on treatment on Dose Level 2 throughout the remainder of trial participation. For the purposes of adverse event reporting, this patient has been included in Dose Level 2.

Cycle 0 Dose: Olaparib 200 mg PO BID; Cycle 1+ Dose: Olaparib 200 mg PO BID, Onalespib 20 mg/m2 IV on days 1, 2, 8, 9, 15, and 16

Dose Level 0

Cycle 0 Dose: Olaparib 200 mg PO BID; Cycle 1+ Dose: Olaparib 200 mg PO BID, Onalespib 40 mg/m2 IV on days 1, 2, 8, 9, 15, and 16

Dose Level 1

Cycle 0 Dose: Olaparib 300 mg PO BID; Cycle 1+ Dose: Olaparib 300 mg PO BID, Onalespib 40 mg/m2 IV on days 1, 2, 8, 9, 15, and 16

Dose Level 2

Cycle 0 Dose: Olaparib 300 mg PO BID; Cycle 1+ Dose: Olaparib 300 mg PO BID, Onalespib 80 mg/m2 IV on days 1, 2, 8, 9, 15, and 16

Dose Level 3

Cycle 0 Dose: Olaparib 200 mg PO BID; Cycle 1+ Dose: Olaparib 200 mg PO BID, Onalespib 80 mg/m2 IV on days 1, 2, 8, 9, 15, and 16

Dose Level 2a

Cycle 0 Dose: Olaparib 200 mg PO BID; Cycle 1+ Dose: Olaparib 200 mg PO BID, Onalespib 120 mg/m2 IV on days 1, 2, 8, 9, 15, and 16

Dose Level 3a

Dose Level 0: Olaparib 200 mg and Onalespib 20 mg/m^2

Dose Level 1: Olaparib 200 mg and Onalespib 40 mg/m^2

Dose Level 2: Olaparib 300 mg and Onalespib 40 mg/m^2

Dose Level 3: Olaparib 300 mg and Onalespib 80 mg/m^2

Dose Level 2a: Olaparib 200 mg and Onalespib 80 mg/m^2

Dose Level 3a: Olaparib 200 mg and Onalespib 120 mg/m^2

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

ECOG Performance Status

Primary Site of Disease

Measure Description: Staging was based on the FIGO (International Federation of Gynecology and Obstetrics) and AJCC (American Joint Committee on Cancer) systems. Stage I cancers usually have not grown deeply into nearby tissues. Stage II and III cancers have grown more deeply into nearby tissue and may have spread to lymph nodes. Stage IV cancers have spread to other organs or parts of the body. Higher stages are typically associated with worse outcomes.

Stage at Diagnosis

Histology

Lines of Prior Therapy

Dr. Panagiotis Konstantinopoulos

Dose Level 2 Olaparib PO BID

Dose Level 2a Olaparib PO BID

All participants who received at least 75% of planned olaparib and at least 4 doses of onalespib within the DLT period.

All Evaluable Participants

Seven of the 28 patients were not evaluable for DLT assessment and were replaced.

Maximum Tolerated Dose (MTD) of Olaparib Administered in Combination With Onalespib

Dose Level 2 Onalespib IV on Days 1, 2, 8, 9, 15, and 16

Dose Level 2a Onalespib IV on Days 1, 2, 8, 9, 15, and 16

Maximum Tolerated Dose (MTD) of Onalespib Administered in Combination With Olaparib

Dose Level 3: Olaparib 300 mg and Onalespib 80 mg/m^

Patients were considered not evaluable for the DLT outcome if they did not receive at least 75% of the planned olaparib doses or at least 4 doses of onalespib for reasons other than toxicity or DLT. Dose Level 3a did not complete evaluation as enrollment was suspended due to discontinuation of further development of onalespib.

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Diarrhea : Maximum Grade 1-2

Diarrhea : Maximum Grade 3

Nausea : Maximum Grade 1-2

Nausea : Maximum Grade 3

Anemia : Maximum Grade 1-2

Anemia : Maximum Grade 3

Thrombocytopenia/platelet count decrease : Maximum Grade 1-2

Thrombocytopenia/platelet count decrease : Maximum Grade 3

Fatigue : Maximum Grade 1-2

Vomiting : Maximum Grade 1-2

Vomiting : Maximum Grade 3

Abdominal pain : Maximum Grade 1-2

Abdominal pain : Maximum Grade 3

Anorexia : Maximum Grade 1-2

Neutrophil count decreased : Maximum Grade 1-2

Neutrophil count decreased : Maximum Grade 4

Lymphocyte count decreased : Maximum Grade 1-2

Lymphocyte count decreased : Maximum Grade 3

Floaters : Maximum Grade 1-2

Dysgeusia : Maximum Grade 1-2

Number of Participants Who Experienced Treatment-Related Toxicities

Only participants who had their disease re-evaluated via CT or MRI were considered evaluable for response. Six of the 28 participants were taken off study therapy prior to their first on-study disease evaluation.

Number of Participants With Objective Responses by RECIST 1.1

Number of Participants Progression-Free for At Least 24 Weeks by RECIST 1.1

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neuroendocrine Tumor

Neuroepithelioma

Trametinib

Dabrafenib

Protein Kinase Inhibitors

Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28, and onalespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Pharmacological Study

Ryan J Sullivan

This phase I trial studies the side effects and best dose of onalespib when given together with dabrafenib and trametinib in treating patients with BRAF-mutant melanoma or solid tumors that have spread to another place in the body (metastatic) or cannot be removed by surgery. Onalespib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD), toxicity, and safety profile of onalespib (AT13387) given weekly in combination with dabrafenib and trametinib in patients with BRAF-mutant metastatic or unresectable solid tumors.

SECONDARY OBJECTIVES:

I. To obtain preliminary estimates of the objective response rate (ORR) and progression-free survival (PFS) and document the 6-month PFS and 1-year overall survival (OS) of patients with BRAF-mutant metastatic or unresectable melanoma treated with AT13387 given weekly in combination with dabrafenib and trametinib.

II. To describe the pharmacokinetics of treatment with dabrafenib, trametinib, and AT13387.

OUTLINE: This is a dose-escalation study of onalespib.

Patients receive dabrafenib orally (PO) twice daily (BID), trametinib PO once daily (QD) on days 1-28, and onalespib intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days and every 6 months for up to 2 years.

Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Phase I Study of AT13387 in Combination With Dabrafenib and Trametinib in Patients With BRAF-Mutant Melanoma and Other Solid Tumors

Descriptive statistics including mean, standard deviation, coefficient of variation, geometric mean, median, minimum and maximum will be computed for each pharmacokinetic variable; descriptive statistics for natural-log transformed pharmacokinetic variables will also be provided.

Will be performed to assess how changes in the expression of the key signaling proteins relate to patient response.

Toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0. Toxicity rates will be summarized with a 90% exact binomial confidence interval.

The response rate will be presented as a point estimate with a 90% exact binomial confidence interval.

The distribution of progression-free survival will be summarized using the product-limit method of Kaplan-Meier.

Median times for each endpoint will be presented with two-sided, 90% confidence intervals estimated using log(-log\[survival\]) methodology. Kaplan-Meier estimates of 6-month progression-free survival will also be presented with two-sided, 90% confidence intervals.

The distribution of overall survival will be summarized using the product-limit method of Kaplan-Meier. Kaplan-Meier estimates of 1-year overall survival will also be presented with two-sided, 90% confidence intervals.

The one-year disease-free survival after treatment will be estimated using the product-limit methods of Kaplan-Meier, and presented with 90% confidence intervals.

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

SAFETY RUN-IN: Patients receive onalespib IV over approximately 1 hour on day -7.

TREATMENT: Patients receive paclitaxel IV over 60 minutes on day 1, 8, and 15. Patients also receive onalespib IV over 1 hour beginning on days 8 and 15 of cycle 1 and on days 1, 8, and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Robert Wesolowski

This phase Ib trial studies the side effects and best dose onalespib when given together with paclitaxel in treating patients with triple negative breast cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Onalespib works by blocking proper processing of proteins that are important for cancer growth. This results in inability of these proteins to work properly. Paclitaxel kills breast cancer cells by interfering with their ability to divide. Giving onalespib together with paclitaxel may be better than giving either one alone in treating patients with breast cancer.

PRIMARY OBJECTIVES:

I. To determine the recommended phase 2 dose (RP2D) of onalespib (AT13387) in combination with paclitaxel in patients with advanced triple negative breast cancer (TNBC).

II. To determine the toxicity profile (based on Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\]5.0) of the combination of AT13387 in combination with paclitaxel in patients with advanced TNBC.

SECONDARY OBJECTIVES:

I. To determine the effect of AT13387 on pharmacokinetics of paclitaxel in the study patient population.

II. To determine the effect of paclitaxel on pharmacokinetics of AT13387 in the study patient population.

III. To observe anti-tumor activity determining the overall response rate (partial response + complete response), response duration and progression-free survival.

OUTLINE: This is a dose-escalation study of onalespib.

SAFETY RUN-IN: Patients receive onalespib intravenously (IV) over 1 hour on day -7.

TREATMENT: Patients receive paclitaxel IV over 60 minutes on day 1, 8, and 15. Patients also receive onalespib IV over 1 hour beginning on days 8 and 15 of cycle 1 and on days 1, 8, and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer

Phase 1b Study of HSP90 Inhibitor, AT13387 (Onalespib) in Combination With Paclitaxel in Patients With Advanced, Triple Negative Breast Cancer

Defined as level at which no more than 1 of 6 patients experience a dose limiting toxicity (maximum tolerated dose or \[MTD\]); or doses of the combination below MTD, if in the opinion of the investigators, lower doses are better tolerated and safer.

Will be based on the Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0.

A descriptive analysis will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).

Will be assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Overall response will be assessed in all patients in an exploratory manner, using summary statistics, by dose level. Will also calculate corresponding 95% binomial confidence intervals for these response rates.

Will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Progression free survival will be summarized using Kaplan and Meier methods, where patients who are event-free at the time of their last evaluation will be censored at that time point.

Shock

Cyclin-Dependent Kinase Inhibitor Proteins

Patients receive onalespib IV over 1 hour on days 1 and 4 (cycle 0 only). Patients then receive onalespib IV over 1 hour and CDKI AT7519 IV over 1 hour on days 1, 4, 8, and 11 (cycle 1 and subsequent cycles thereafter). Cycles repeat every 21 days (7 days for course 0 only) in the absence of disease progression or unacceptable toxicity.

CDK Inhibitor AT7519

Khanh T Do

This phase I trial studies the side effects and best dose of onalespib and CDKI AT7519 in treating patients with solid tumors that have spread from the primary site (place where they started) to other places in the body (metastatic) or cannot be removed by surgery. Onalespib and CDKI AT7519 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To establish the safety, tolerability, and the maximum tolerated dose of the combination of onalespib and AT7519M (CDKI AT7519).

SECONDARY OBJECTIVES:

I. To determine the pharmacokinetics of the combination of onalespib and AT7519M.

II. To assess the pharmacodynamic effect of the combination of onalespib and AT7519M on HSP70 expression and modulation of HSP90 client proteins in peripheral blood mononuclear cells (PBMCs), plasma, and tumor biopsies.

III. To observe and record anti-tumor activity.

OUTLINE: This is a dose-escalation study.

Patients receive onalespib intravenously (IV) over 1 hour on days 1 and 4 (cycle 0 only). Patients then receive onalespib IV over 1 hour and CDKI AT7519 IV over 1 hour on days 1, 4, 8, and 11 (cycle 1 and subsequent cycles thereafter). Cycles repeat every 21 days (7 days for course 0 only) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Onalespib and CDKI AT7519 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

A Phase 1 Trial of the Combination of the Heat Shock Protein-90 (HSP90) Inhibitor Onalespib (AT13387) and the Cyclin-Dependent Kinase (CDK) Inhibitor AT7519M in Patients With Advanced Solid Tumors

Scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Assessed using the NCI CTCAE version 5.0.

Defined as =\< 1 out of 6 patients experiencing dose limiting toxicity.

Individual patient plasma concentration-time curves will be analyzed by noncompartmental methods using routines supplied in the WinNonlin Professional Version 4.0.1 software package. Pharmacokinetic parameters and variables will be calculated according to standard equations. Mean values of the pharmacokinetic parameters will be statistically compared using the paired two-tailed t-test of the log-transformed data.

PD effect of the combination of onalespib and CDKI AT7519 on Hsp70 expression and modulation of Hsp90 client proteins in peripheral blood mononuclear cells (PBMCs) will be assessed. All PD evaluations and comparisons will be done with exploratory intent, using primarily descriptive and non-parametric techniques.

Measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1).

Blood and Lymph Conditions

Immune System Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, B-Cell

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, T-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Anaplastic Large Cell Lymphoma

Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer	NCT02898207	Metastatic High... Metastatic Mali... Metastatic Prim... Metastatic Trip... Platinum-Resist... Platinum-Resist... Platinum-Resist... Recurrent Breas... Recurrent High ... Recurrent High ... Recurrent Prima... Recurrent Tripl... Refractory Fall... Refractory Ovar... Refractory Prim... Refractory Trip... Unresectable Hi... Unresectable Ma... Unresectable Pr...	Olaparib Onalespib	18 Years -	National Cancer Institute (NCI)
Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery	NCT02097225	BRAF V600E Muta... BRAF V600K Muta... Metastatic Mali... Metastatic Mela... Stage III Cutan... Stage IIIA Cuta... Stage IIIB Cuta... Stage IIIC Cuta... Stage IV Cutane... Unresectable So...	Dabrafenib Laboratory Biom... Onalespib Pharmacological... Trametinib	18 Years -	National Cancer Institute (NCI)
Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer	NCT02474173	Advanced Breast... Metastatic Brea... Stage III Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea... Stage IV Breast... Triple-Negative...	Laboratory Biom... Onalespib Paclitaxel Pharmacological...	18 Years -	National Cancer Institute (NCI)
Onalespib and CDKI AT7519 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery	NCT02503709	Advanced Malign... Metastatic Mali... Unresectable So...	CDK Inhibitor A... Laboratory Biom... Onalespib Pharmacological...	18 Years -	National Cancer Institute (NCI)
Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery	NCT02097225	BRAF V600E Muta... BRAF V600K Muta... Metastatic Mali... Metastatic Mela... Stage III Cutan... Stage IIIA Cuta... Stage IIIB Cuta... Stage IIIC Cuta... Stage IV Cutane... Unresectable So...	Dabrafenib Laboratory Biom... Onalespib Pharmacological... Trametinib	18 Years -	National Cancer Institute (NCI)
Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL	NCT02572453	Recurrent Anapl... Recurrent Diffu... Recurrent Mantl... Recurrent Trans... Refractory Anap... Refractory Diff... Refractory Mant... Refractory Tran...	Onalespib	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for onalespib

Every month we try and update this database with for onalespib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for onalespib

Every month we try and update this database with for onalespib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for onalespib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.