Trial · NCT00521144
Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors
NCT00521144, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors. Trials, record NCT00521144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00521144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors
- NCT number
- NCT00521144
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Small Cell Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- obatoclax mesylate, topotecan hydrochloride, laboratory biomarker analysis
- First posted
- 2007-08-27
- Last updated
- 2015-05-05
- Results first posted
- 2014-07-22
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (Phase II) | Every 6 weeks, assessed up to 30 days | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (Phase II) | Every 6 weeks, assessed up to 30 days | Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (Phase II) | Phase I; Level 1: Obatoclax Mesylate + Topetecan | 0 | participants | ||
| Overall Response Rate (Phase II) | Phase I; Level 2: Obatoclax Mesylate + Topetecan | 0 | participants | ||
| Overall Response Rate (Phase II) | Phase I; Level 3: Obatoclax Mesylate + Topetecan | 0 | participants | ||
| Overall Response Rate (Phase II) | Phase II Obatoclax Mesylate + Topotecan in SCLC | 0 | participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I; Level 1: Obatoclax Mesylate + Topetecan | 6 | |
| Overall Study | STARTED | Phase I; Level 2: Obatoclax Mesylate + Topetecan | 5 | |
| Overall Study | STARTED | Phase I; Level 3: Obatoclax Mesylate + Topetecan | 3 | |
| Overall Study | STARTED | Phase I; Level 4: Obatoclax Mesylate + Topotecan | 1 | |
| Overall Study | STARTED | Phase II Obatoclax Mesylate + Topotecan in SCLC | 7 | |
| Overall Study | COMPLETED | Phase I; Level 1: Obatoclax Mesylate + Topetecan | 2 | |
| Overall Study | COMPLETED | Phase I; Level 2: Obatoclax Mesylate + Topetecan | 2 | |
| Overall Study | COMPLETED | Phase I; Level 3: Obatoclax Mesylate + Topetecan | 1 | |
| Overall Study | COMPLETED | Phase I; Level 4: Obatoclax Mesylate + Topotecan | 0 | |
| Overall Study | COMPLETED | Phase II Obatoclax Mesylate + Topotecan in SCLC | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anorexia | Metabolism and nutrition disorders | Phase I; Level 1: Obatoclax Mesylate + Topotecan | 0 | 6 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Phase I; Level 2: Obatoclax Mesylate + Topotecan | 0 | 5 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Phase I; Level 3: Obatoclax Mesylate + Topotecan | 0 | 3 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Phase I; Level 4: Obatoclax Mesylate + Topotecan | 0 | 1 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Phase II Obatoclax Mesylate + Topotecan in SCLC | 2 | 7 | 2 |
| other | Ataxia (incoordination) | Nervous system disorders | Phase I; Level 1: Obatoclax Mesylate + Topotecan | 5 | 6 | 11 |
| other | Ataxia (incoordination) | Nervous system disorders | Phase I; Level 2: Obatoclax Mesylate + Topotecan | 2 | 5 | 6 |
| other | Ataxia (incoordination) | Nervous system disorders | Phase I; Level 3: Obatoclax Mesylate + Topotecan | 2 | 3 | 4 |
| other | Ataxia (incoordination) | Nervous system disorders | Phase I; Level 4: Obatoclax Mesylate + Topotecan | 0 | 1 | 0 |
| other | Ataxia (incoordination) | Nervous system disorders | Phase II Obatoclax Mesylate + Topotecan in SCLC | 7 | 7 | 21 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I; Level 1: Obatoclax Mesylate + Topotecan | ||
| Total, all-cause mortality | Phase I; Level 2: Obatoclax Mesylate + Topotecan | ||
| Total, all-cause mortality | Phase I; Level 3: Obatoclax Mesylate + Topotecan | ||
| Total, all-cause mortality | Phase I; Level 4: Obatoclax Mesylate + Topotecan | ||
| Total, all-cause mortality | Phase II Obatoclax Mesylate + Topotecan in SCLC | ||
| Total, other adverse events | Phase I; Level 1: Obatoclax Mesylate + Topotecan | 6 | 6 |
| Total, other adverse events | Phase I; Level 2: Obatoclax Mesylate + Topotecan | 3 | 5 |
| Total, other adverse events | Phase I; Level 3: Obatoclax Mesylate + Topotecan | 2 | 3 |
| Total, other adverse events | Phase I; Level 4: Obatoclax Mesylate + Topotecan | 0 | 1 |
| Total, other adverse events | Phase II Obatoclax Mesylate + Topotecan in SCLC | 7 | 7 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21620511 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00521144
GET https://conductscience.org/api/trials/v1/NCT00521144/events?page=2